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Center for Global Research Data

An individual participant data meta-analysis to evaluate a new category of hypoglycemic drugs (DPP-4Is) 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 (DPP-4Is) on type 2 diabetes mellitus patient sub-groups
Vivli Data Request: 6487
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: dipeptidyl peptidase-4 inhibitors (DPP-4Is) , inhibitors that block the action of DPP-4, an enzyme that destroys the hormone incretin which helps the body produce more insulin only when needed.

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 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 Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23
Data Contributor: Boehringer Ingelheim
Study ID: NCT01289990
Sponsor ID: 1245.31

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 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 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

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