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Center for Global Research Data

An individual participant data meta-analysis to evaluate a new category of hypoglycemic drugs (SGLT-2Is) on type 2 diabetes mellitus patient sub-groups

Lead Investigator: Feng Sun, Peking University
Title of Proposal Research: An individual participant data meta-analysis to evaluate a new category of hypoglycemic drugs (SGLT-2Is) on type 2 diabetes mellitus patient sub-groups
Vivli Data Request: 6488
Funding Source: China National Natural Science Foundation(no.72074011)
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Diabetes- e.g. a condition that occurs when blood glucose in the body is to high- is a group of metabolic diseases characterized by hyperglycemia. Type 2 diabetes mellitus ,where the body does not produce enough insulin by the pancreas to turn glucose into energy, is the most common type of diabetes. Being diagnosed as diabetes often means long-term use of hypoglycemic drugs. In recent years, a series of new hypoglycemic drugs have appeared: sodium-dependent glucose transporter 2 inhibition (SGLT-2Is), inhibitors that block the action of SGLT-2, a transport protein that responsible for the absorption of glucose in the intestinal epithelial cells, the reabsorption in the renal tubules, and the uptake and release of glucose in all cells.

According to the latest data released by the International Diabetes Federation (IDF) in 2019, there are currently 463 million diabetics among adults between 20 and 79 years old in the world. This number is expected to reach 578.4 million by 2030. Diabetes is now a major problem threatening human health, and type 2 diabetes mellitus (T2DM) is the most common type of diabetes. In view of the development of hypoglycemic agents and the growth in the number of people with T2DM, detailed information of these new drugs is needed to provide more reliable basis for clinicians when making decisions, and provide reference for guideline makers and regulatory decision-making departments.

Today, lots of randomized controlled trials (RCTs) comparing the efficacy and safety of these new hypoglycemic drugs have been published, which can be integrated to obtain high-quality evidence. There is a large population of T2DM patients in China, but most RCTs of hypoglycemic drugs were carried out in western populations. Whether the conclusions of these RCTs can be verified in Chinese population is an essential question. Considering that the efficacy and safety of drugs may be affected by many factors, drugs may have different effects on patients with different baseline conditions. The integration of evidence among Chinese population is of great significance to duplicate and verify the effectiveness of RCTs in Chinese real-world studies, in order to further find which kind of new drug is more suitable for Chinese T2DM patients.

Requested Studies:

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 18-Week Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea
Data Contributor: Johnson & Johnson
Study ID: NCT01381900
Sponsor ID: CR018541

A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled on Metformin Monotherapy
Data Contributor: Johnson & Johnson
Study ID: NCT00968812
Sponsor ID: CR016480

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Data Contributor: Johnson & Johnson
Study ID: NCT01081834
Sponsor ID: CR017011

A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients
Data Contributor: Boehringer Ingelheim
Study ID: NCT00881530
Sponsor ID: 1245.24

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 IIb, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (5 mg, 10 mg and 25 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo, as Monotherapy, With an Additional Open-label Metformin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control
Data Contributor: Boehringer Ingelheim
Study ID: NCT00789035
Sponsor ID: 1245.9

A Phase II, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (1 mg, 5 mg, 10 mg, 25 mg, and 50 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo With an Additional Open-label Sitagliptin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control Despite Metformin Therapy
Data Contributor: Boehringer Ingelheim
Study ID: NCT00749190
Sponsor ID: 1245.10