Center for Global Research Data

Real-world treatment effectiveness of novel anti-diabetic agents in people with type 2 diabetes: Maximising the applicability of clinical trials

Lead Investigator: David McAllister, University of Glasgow
Title of Proposal Research: Real-world treatment effectiveness of novel anti-diabetic agents in people with type 2 diabetes: Maximising the applicability of clinical trials
Vivli Data Request: 6115
Funding Source: Medical Research Council UK, reference MR/T017112/1
Potential Conflicts of Interest: None

Summary of the Proposed Research:

To get the best healthcare members of the public need their doctors and other clinical staff to know whether new treatments work for them. For example, there are several new classes (types) of drug treatment for diabetes, but which of these are most effective in real-world settings is uncertain. This work sets out to determine which of three new drug classes for type 2 diabetes are most effective in real-world settings. Around 6% of the population of the UK has diabetes (with similar proportions in the US and Europe) this uncertainty is therefore an issue for a large number of people.

The best way to know whether a new medicine works is to perform a randomised clinical trial. In clinical trials, participants are selected to have different medicines at random (i.e. by chance). As a result, participants receiving different treatments are, on average, similar. Consequently, researchers can compare groups receiving different treatments, and decide which are the most effective. However, trial participants are commonly younger and fitter than other patients. As a result, clinicians and others have expressed uncertainty as to whether results from trials are relevant to many patients in “real-world” settings.

To address this concern, some researchers have instead studied treatments using “routine data”. Unlike with trials, routine data can be collected from all patients receiving healthcare (e.g. from medical records) including many older frailer patients.

However, when this kind of data is used to compare treatments it is very difficult to be sure (even with very sophisticated statistical methods) that any differences have been caused by the medication. This is because, unlike in trials, different treatments are often offered (or not offered) to patients because of differences in their clinical features.

In this project, we propose to overcome the weaknesses of clinical trials and of routine data by using the strengths of both. We will use routine data to “calibrate” trial results. When trial results are calibrated, findings from under-represented groups (e.g. older women) influence the overall results more than findings from other over-represented groups (e.g. younger men). After calibration we can be more confident that the trial results are relevant. Calibration does not “break” the randomness of trials; calibrated results remain reliable.

Some older calibration methods required researchers to have access to very detailed results from every relevant trial (e.g. the result for every trial participant). In most situations, this meant calibration was unfeasible. However, we recently developed a method to perform calibration which does not require this level of detail for every trial. This calibration is feasible for many more conditions and treatments. We now propose, for the first time, to use this new method to calibrate trials using routine data. Specifically, we will perform the calibration to decide which of the newer diabetes medicines are most effective in real-world patients in Scotland, England, and China. We will obtain routine data from a complete register of people with diabetes in Scotland, a routine data registry in England and from two hospitals in China. Having identified a group of patients suitable for treatment with the newer medicines, we will calculate the likely benefits and harms of each of the newer medicines as if the original clinical trials had been conducted in China, in Scotland or in England.

We will produce an overall summary result from all the trials, making this available to clinicians and people with diabetes. Since around 6% of the population of the UK has diabetes (with similar proportions in the US and Europe) this has the potential to benefit a large number of people.

We will also feed the results into a health economic model to predict the likely costs, benefits, and value for money. Such models are used by organisations such as the National Institute for Health and Care Excellence (NICE) to inform guidelines and regulations about medicines.

To better communicate our findings about the effectiveness and value for money of each medicine, we will develop an interactive web app, designed to be used by researchers, clinicians, and people with diabetes. It will allow users to compare results which have been obtained the conventional way, alongside results obtained using calibration.
This project will produce results about differences in the effectiveness of newer drugs for diabetes that are reliable, and that clinicians can confidently apply to patients with diabetes in the real-world settings studied. As well producing tangible benefits for people with diabetes, this will also demonstrate methodologically, for the first time, that calibration can improve the relevance of trial results.

Requested Studies:

A Repeat-dose Study in Subjects With Type 2 Diabetes Mellitus to Assess the Efficacy, Safety, Tolerability and Pharmacodynamics, of Albiglutide Liquid Drug Product
Data Contributor: GlaxoSmithKline
Study ID: NCT02683746
Sponsor ID: 200952

A Randomized, Parallel-Arm, Double-Blind Study of Efficacy and Safety of Dulaglutide When Added to SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus
Data Contributor: Lilly
Study ID: NCT02597049
Sponsor ID: 15361

A Long Term, Randomised, Double Blind, Placebo-controlled Study to Determine the Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Patients With Type 2 Diabetes Mellitus
Data Contributor: GlaxoSmithKline
Study ID: NCT02465515
Sponsor ID: GLP116174

A Randomized, Double-Blind Trial Comparing the Effect of Dulaglutide 1.5 mg With Placebo on Glycemic Control in Patients With Type 2 Diabetes on Basal Insulin Glargine
Data Contributor: Lilly
Study ID: NCT02152371
Sponsor ID: 13195

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Alogliptin and Metformin Fixed Dose Combination, Alogliptin Alone, or Metformin Alone in Subjects With Type 2 Diabetes Mellitus
Data Contributor: Takeda
Study ID: NCT01890122
Sponsor ID: SYR-322MET_303

A Phase IIIb, Multicenter, Multinational, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Glycemic and Renal Efficacy of Once Daily Administration of Linagliptin 5 mg for 24 Weeks in Type 2 Diabetes Patients, With Micro- or Macroalbuminuria (30-3000mg/g Creatinine) on Top of Current Treatment With Angiotensin ConvEnzyme Inhibitor or Angiotensin Receptor Blocker – MARLINA (Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin)
Data Contributor: Boehringer Ingelheim
Study ID: NCT01792518
Sponsor ID: 1218.89

A Phase III, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Linagliptin 5 mg Compared to Placebo, Administered as Oral Fixed Dose Combination With Empagliflozin 10 mg or 25 mg for 24 Weeks, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks of Treatment With Empagliflozin 10 mg or 25 mg on Metformin Background Therapy
Data Contributor: Boehringer Ingelheim
Study ID: NCT01778049
Sponsor ID: 1275.10

A Randomized, Parallel-Arm, Double-Blinded Study Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Patients With Type 2 Diabetes Mellitus on Sulfonylurea Therapy (AWARD-8: Assessment of Weekly AdministRation of LY2189265 in Diabetes – 8)
Data Contributor: Lilly
Study ID: NCT01769378
Sponsor ID: 13193

A Phase III, Randomised, Double-blind, Parallel Group, 24 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and 25 mg Compared to Placebo, All Administered as Oral Fixed Dose Combinations With Linagliptin 5 mg, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks Treatment With Linagliptin 5 mg Once Daily on Metformin Background Therapy.
Data Contributor: Boehringer Ingelheim
Study ID: NCT01734785
Sponsor ID: 1275.9

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Monotherapy Study to Determine the Efficacy and Safety of 2 Dose Levels of Albiglutide in Subjects With Type 2 Diabetes Mellitus
Data Contributor: GlaxoSmithKline
Study ID: NCT01733758
Sponsor ID: 113121

A 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes Mellitus
Data Contributor: Boehringer Ingelheim
Study ID: NCT01719003
Sponsor ID: 1276.1

A Phase III Randomised, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Fix Dose Combination of Linagliptin 2.5 mg + Metformin 500 mg, or of Linagliptin 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg, Twice Daily), and Linagliptin (5.0 mg, Once Daily) Over 24 Weeks in Treatment naïve Type 2 Diabetic Patients With Insufficient Glycaemic Control
Data Contributor: Boehringer Ingelheim
Study ID: NCT01708902
Sponsor ID: 1288.18

A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-Weekly Dulaglutide With Once-Daily Liraglutide in Patients With Type 2 Diabetes (AWARD-6: Assessment of Weekly AdministRation of LY2189265 in Diabetes-6)
Data Contributor: Lilly
Study ID: NCT01624259
Sponsor ID: 11377

A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-weekly Dulaglutide With Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes and Moderate or Severe Chronic Kidney Disease
Data Contributor: Lilly
Study ID: NCT01621178
Sponsor ID: 13798

A Randomised, Double-blind, Double-dummy, Active-comparator Controlled Study Investigating the Efficacy and Safety of Linagliptin Co-administered With Metformin QD at Evening Time Versus Metformin BID Over 14 Weeks in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
Data Contributor: Boehringer Ingelheim
Study ID: NCT01438814
Sponsor ID: 1218.60

A Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Individual Components (BI 10773 25 mg, BI 10773 10 mg, and Linagliptin 5 mg) for 52 Weeks in Treatment naïve and Metformin Treated Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
Data Contributor: Boehringer Ingelheim
Study ID: NCT01422876
Sponsor ID: 1275.1

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 12 Weeks in Hypertensive Patients With Type 2 Diabetes Mellitus
Data Contributor: Boehringer Ingelheim
Study ID: NCT01370005
Sponsor ID: 1245.48

A 52-week, Randomised, Multi-centre, Parallel Group Study to Investigate the Safety and Efficacy of BI 10773 (10 mg or 25 mg Administered Orally Once Daily) as add-on Therapy to an Oral Antidiabetic Drug (Sulfonylurea, Biguanide, Thiazolidinedione, Alpha Glucosidase Inhibitor, DPP-IV Inhibitor, or Glinide) in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
Data Contributor: Boehringer Ingelheim
Study ID: NCT01368081
Sponsor ID: 1245.52

A Phase III, Randomized, Double-blind, Placebo-controlled, Parallel Group Safety and Efficacy Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) During 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control on MDI Insulin Regimen Alone or With Metformin
Data Contributor: Boehringer Ingelheim
Study ID: NCT01306214
Sponsor ID: 1245.49

A Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 Over 24 Weeks in T2D Patients With Insufficient Glycaemic Control Despite Metformin Therapy
Data Contributor: Boehringer Ingelheim
Study ID: NCT01215097
Sponsor ID: 1218.65

A Randomized, db, Placebo Controlled Parallel Group Efficacy and Safety Study Over 24 Weeks in T2D Patients in China
Data Contributor: Boehringer Ingelheim
Study ID: NCT01214239
Sponsor ID: 1218.66

A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Trial of BI 10773 (10 and 25 mg Administered Orally Once Daily) Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite a Background Therapy of Pioglitazone Alone or in Combination With Metformin
Data Contributor: Boehringer Ingelheim
Study ID: NCT01210001
Sponsor ID: 1245.19

An Open Label, Randomised, Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Background Mono-therapy With an Approved Antidiabetic Drug
Data Contributor: Boehringer Ingelheim
Study ID: NCT01204294
Sponsor ID: 1218.78

The Impact of LY2189265 Versus Insulin Glargine in Combination With Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus (AWARD-4: Assessment of Weekly AdministRation of LY2189265 in Diabetes – 4)
Data Contributor: Lilly
Study ID: NCT01191268
Sponsor ID: 11376

A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 10773 and Sitagliptin Administered Orally Over 24 Weeks, in Drug naïve Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Diet and Exercise
Data Contributor: Boehringer Ingelheim
Study ID: NCT01177813
Sponsor ID: 1245.20

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control
Data Contributor: Boehringer Ingelheim
Study ID: NCT01164501
Sponsor ID: 1245.36

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea
Data Contributor: Boehringer Ingelheim
Study ID: NCT01159600
Sponsor ID: 1245.23

A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide in Subjects With Type 2 Diabetes Mellitus
Data Contributor: GlaxoSmithKline
Study ID: NCT01128894
Sponsor ID: 114179

The Impact of LY2189265 Versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3)
Data Contributor: Lilly
Study ID: NCT01126580
Sponsor ID: 11375

A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Renal Impairment
Data Contributor: GlaxoSmithKline
Study ID: NCT01098539
Sponsor ID: 114130

A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Glimepiride
Data Contributor: Lilly
Study ID: NCT01075282
Sponsor ID: 11374

A Randomized, Placebo-Controlled Comparison of the Effects of Two Doses of LY2189265 or Exenatide on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Pioglitazone (AWARD-1: Assessment of Weekly Administration of LY2189265 in Diabetes-1)
Data Contributor: Lilly
Study ID: NCT01064687
Sponsor ID: 11373

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Alogliptin Plus Metformin, Alogliptin Alone, or Metformin Alone in Subjects With Type 2 Diabetes
Data Contributor: Takeda
Study ID: NCT01023581
Sponsor ID: SYR-322MET_302

A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine as Compared With the Combination of Insulin Glargine and Preprandial Lispro Insulin in Subjects With Type 2 Diabetes Mellitus
Data Contributor: GlaxoSmithKline
Study ID: NCT00976391
Sponsor ID: GLP108486

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome
Data Contributor: Takeda
Study ID: NCT00968708
Sponsor ID: SYR-322_402

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group Efficacy and Safety Study of Linagliptin (5 mg), Administered Orally Once Daily for at Least 52 Weeks in Type 2 Diabetic Patients in Combination With Basal Insulin Therapy
Data Contributor: Boehringer Ingelheim
Study ID: NCT00954447
Sponsor ID: 1218.36

A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination With Metformin in Subjects With Type 2 Diabetes
Data Contributor: Takeda
Study ID: NCT00856284
Sponsor ID: SYR-322_305

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Pioglitazone With or Without Metformin in Subjects With Type 2 Diabetes Mellitus
Data Contributor: GlaxoSmithKline
Study ID: NCT00849056
Sponsor ID: GLP112755

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Two Dose Levels of Albiglutide Compared With Placebo in Subjects With Type 2 Diabetes Mellitus
Data Contributor: GlaxoSmithKline
Study ID: NCT00849017
Sponsor ID: 112756

A Randomized, Double-blind, Placebo and Active-Controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide Administered in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and With Metformin Plus Glimepiride and Pioglitazone in Subjects With Type 2 Diabetes Mellitus
Data Contributor: GlaxoSmithKline
Study ID: NCT00839527
Sponsor ID: GLP112757

A Randomized, Open-label, Parallel-group, Multicenter Study to Determine the Efficacy and Long-term Safety of Albiglutide Compared With Insulin in Subjects With Type 2 Diabetes Mellitus.
Data Contributor: GlaxoSmithKline
Study ID: NCT00838916
Sponsor ID: GLP112754

A Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Metformin Compared With Metformin Plus Sitagliptin, Metformin Plus Glimepiride, and Metformin Plus Placebo in Subjects With Type 2 Diabetes Mellitus
Data Contributor: GlaxoSmithKline
Study ID: NCT00838903
Sponsor ID: 112753

A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Free Combination of BI 1356 2.5 mg + Metformin 500 mg, or of BI 1356 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg Twice Daily), and BI 1356 (5.0 mg Once Daily) Over 24 Weeks in Drug Naive or Previously Treated (4 Weeks Wash-out and 2 Weeks Placebo run-in) Type 2 Diabetic Patients With Insufficient Glycaemic Control
Data Contributor: Boehringer Ingelheim
Study ID: NCT00798161
Sponsor ID: 1218.46

A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin
Data Contributor: Lilly
Study ID: NCT00734474
Sponsor ID: 11422

A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Subjects With Type 2 Diabetes
Data Contributor: Takeda
Study ID: NCT00707993
Sponsor ID: SYR-322_303

A Double-blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control, Followed by an Extension Study to 52 Weeks to Evaluate Long-term Safety
Data Contributor: Boehringer Ingelheim
Study ID: NCT00654381
Sponsor ID: 1218.23

A Randomised, Double-blind, Placebo Controlled, Parallel Group 24 Week Study to Assess the Efficacy and Safety of BI 1356 (5 mg) in Combination With 30 mg Pioglitazone (Both Administered Orally Once Daily), Compared to 30 mg Pioglitazone Plus Placebo in Drug Naive or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control.
Data Contributor: Boehringer Ingelheim
Study ID: NCT00641043
Sponsor ID: 1218.15

A Randomised Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 1356 ( 5.0 mg, Administered Orally Once Daily) Compared to Glimepiride Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
Data Contributor: Boehringer Ingelheim
Study ID: NCT00622284
Sponsor ID: 1218.20

A Randomised, Double-blind, Placebo-controled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug Naive or Previously Treated (6 Weeks Washout) Type 2 Diabetic Patients With Insufficient Glycemic Control
Data Contributor: Boehringer Ingelheim
Study ID: NCT00621140
Sponsor ID: 1218.16

A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg) Administered Orally Once Daily Over 24 Weeks, With an Open-label Extension to One Year (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With a Sulphonylurea
Data Contributor: Boehringer Ingelheim
Study ID: NCT00602472
Sponsor ID: 1218.18

A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
Data Contributor: Boehringer Ingelheim
Study ID: NCT00601250
Sponsor ID: 1218.17

A Multicenter, Randomized, Double-Blind Study to Determine the Efficacy and Safety of the Addition of SYR-322 25 mg Versus Dose Titration From 30 mg to 45 mg of Pioglitazone HCl (ACTOS®) in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Control on a Combination of Metformin and 30 mg of Pioglitazone HCl Therapy
Data Contributor: Takeda
Study ID: NCT00432276
Sponsor ID: 01-06-TL-322OPI-004

A Multicenter, Double-Blind Study to Determine the Efficacy and Safety of SYR-322 Plus Pioglitazone HCl (Actos®), SYR-322 Alone or Pioglitazone HCl Alone in Subjects With Type 2 Diabetes
Data Contributor: Takeda
Study ID: NCT00395512
Sponsor ID: 01-06-TL-322OPI-002

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of the Combination of SYR-322 (SYR110322) and Pioglitazone HCl (ACTOS®), in Subjects With Type 2 Diabetes
Data Contributor: Takeda
Study ID: NCT00328627
Sponsor ID: 01-05-TL-322OPI-001

A Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of SYR110322 (SYR-322) in Subjects With Type 2 Diabetes
Data Contributor: Takeda
Study ID: NCT00306384
Sponsor ID: SYR-322-OLE-012

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With Pioglitazone in Subjects With Type 2 Diabetes Mellitus
Data Contributor: Takeda
Study ID: NCT00286494
Sponsor ID: SYR-322-TZD-009

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With a Sulfonylurea in Subjects With Type 2 Diabetes
Data Contributor: Takeda
Study ID: NCT00286468
Sponsor ID: SYR-322-SULF-007

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) Compared With Placebo in Subjects With Type 2 Diabetes
Data Contributor: Takeda
Study ID: NCT00286455
Sponsor ID: SYR-322-PLC-010

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With Metformin in Subjects With Type 2 Diabetes
Data Contributor: Takeda
Study ID: NCT00286442
Sponsor ID: SYR-322-MET-008

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With Insulin in Subjects With Type 2 Diabetes
Data Contributor: Takeda
Study ID: NCT00286429
Sponsor ID: SYR-322-INS-011

Extension Study Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid Versus Metformin 1000 mg Bid
Data Contributor: Boehringer Ingelheim
Study ID: NCT00915772
Sponsor ID: 1218.52

A Phase III Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 10773 Compared to Glimepiride Administered Orally During 104 Weeks With a 104 Week Extension Period in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Metformin Treatment
Data Contributor: Boehringer Ingelheim
Study ID: NCT01167881
Sponsor ID: 1245.28

A Phase III, Randomised, Double-blind, Parallel Group, 24-week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and Linagliptin 5 mg Fixed Dose Combination Compared With Empagliflozin 10 mg Plus Placebo and a 52-week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 25 mg and Linagliptin 5 mg Fixed Dose Combination Compared With Empagliflozin 25 mg Plus Placebo in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16-week Treatment With Empagliflozin (10 mg or 25 mg) Alone Once Daily.
Data Contributor: Boehringer Ingelheim
Study ID: NCT02489968
Sponsor ID: 1275.13

A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Sulfonylurea in Subjects With Type 2 Diabetes in Japan
Data Contributor: Takeda
Study ID: NCT01318083
Sponsor ID: SYR-322/CCT-005

A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Thiazolidine in Subjects With Type 2 Diabetes in Japan
Data Contributor: Takeda
Study ID: NCT01318070
Sponsor ID: SYR-322/CCT-004

A Multi-Center, Randomized, Double-Blind, Active-Controlled , Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin 5mg Co-administered With Dapagliflozin 5mg Compared to Saxagliptin 5mg or Dapagliflozin 5mg All Given as Add-on Therapy to Metformin inPatients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Alone
Data Contributor: AstraZeneca
Study ID: NCT02681094
Sponsor ID: D1683C00005

A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin Plus Saxagliptin Compared With Sulphonylurea All Given as Add-on Therapy to Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy
Data Contributor: AstraZeneca
Study ID: NCT02471404
Sponsor ID: D1689C00014

A 26-week International, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3bTrial With a Blinded 26-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Data Contributor: AstraZeneca
Study ID: NCT02284893
Sponsor ID: CV181-363

Study 200977: Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine in the Treatment of Subjects With Type 2 Diabetes Mellitus: The Switch Study
Data Contributor: GlaxoSmithKline
Study ID: NCT02229227
Sponsor ID: 200977

A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy With Saxagliptin and Dapagliflozin Added to Metformin Compared to Add-On Therapy With Saxagliptin in Combination With Metformin or Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone.
Data Contributor: AstraZeneca
Study ID: NCT01606007
Sponsor ID: CV181-169

A 16-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD Versus Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled on Metformin-IR Monotherapy
Data Contributor: AstraZeneca
Study ID: NCT01217892
Sponsor ID: D1691C00003

An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Determine the Efficacy and Safety of SYR-322 When Used in Subjects With Type 2 Diabetes
Data Contributor: Takeda
Study ID: NCT01289119
Sponsor ID: SYR-322_308