9 completed, 1 suspended, 1 terminated. 5 Phase 3, 4 Phase 1, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 5 | Completed 4, Suspended 1 |
| Phase 1 | 4 | Completed 3, Terminated 1 |
| Phase 4 | 2 | Completed 2 |
Follow Metformin IR: new trials by email Literature Review of Metformin IR trials Research Report on Metformin IR
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase 1 Study of ANJ900 Chinese Healthy Subjects ANJ900, Metformin IR - Healthy | Phase 1 | Completed | Anji Pharma | 18 | 2021-10-15 | 2022-06-08 |
| Investigational Study of Delayed Release Metformin Metformin DR, Metformin IR, Metformin DR Placebo - Diabetes Mellitus, Type 2 | Phase 3 | Suspended | Anji Pharma | 675 | 2021-05-18 | 2023-03-14 |
| Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults (Phase 1 Study) DWP16001, Metformin IR, DWP16001+Metformin IR - Healthy | Phase 1 | Completed | Daewoong Pharmaceutical Co. LTD. | 34 | 2019-08-14 | 2020-01-13 |
| A Study of the Safety and Efficacy of Sitagliptin Addition During Metformin Up-titration (MK-0431-848) Sitagliptin, Placebo, Metformin IR - Type 2 Diabetes Mellitus | Phase 3 | Completed | Merck Sharp & Dohme LLC | 458 | 2016-06-16 | 2019-02-28 |
| Metformin Extended Release Versus Metformin Immediate Release in Subjects With Type 2 Diabetes Metformin IR, Metformin XR - Diabetes Mellitus, Type 2 | Phase 4 | Completed | Merck KGaA, Darmstadt, Germany | 532 | 2014-12-01 | 2017-01-24 |
| Bioequivalence Study of Metformin Component of Canagliflozin and Metformin Fixed Dose Combination Immediate Release (IR) Tablet Comparing With Metformin IR Tablet Co-administered With Canagliflozin Tablet in Healthy Fed and Fasted Participants Canagliflozin + Metformin Immediate Release (IR) Fixed Dose Combination (FDC), Canagliflozin, Metformin IR - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 2 | 2014-08-01 | 2014-11-19 |
| Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes Metformin XR, Metformin IR, Placebo matching with Metformin XR - Type 2 Diabetes Mellitus | Phase 4 | Completed | Bristol-Myers Squibb | 1736 | 2013-06-20 | 2019-11-29 |
| Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM Metformin immediate release (IR), Saxagliptin, Metformin IR - Type 2 Diabetes Mellitus | Phase 1 | Terminated | AstraZeneca | 4 | 2012-09-01 | 2015-06-22 |
| Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 Diabetes Saxagliptin, Dapagliflozin, Metformin IR - Type 2 Diabetes | Phase 3 | Completed | AstraZeneca | 315 | 2012-06-01 | 2016-04-22 |
| A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone Placebo matching with Saxagliptin, Metformin IR, Metformin XR - Diabetes Mellitus, Type 2 | Phase 3 | Completed | AstraZeneca | 32 | 2012-05-01 | 2017-04-18 |
| Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes Saxagliptin, Placebo (Saxagliptin), Metformin IR - Type 2 Diabetes | Phase 3 | Completed | AstraZeneca | 26 | 2011-06-01 | 2017-04-18 |
AstraZeneca (4) · Anji Pharma (2) · Bristol-Myers Squibb (1) · Daewoong Pharmaceutical Co. LTD. (1) · Janssen Research & Development, LLC (1) · Merck KGaA, Darmstadt, Germany (1) · Merck Sharp & Dohme LLC (1)
United States (7) · Canada (4) · Czechia (3) · Hungary (3) · Poland (3) · Germany (2) · Mexico (2) · Puerto Rico (2) · Romania (2) · Russia (2) · South Africa (2) · Taiwan (2) · United Kingdom (2) · Belgium (1) · Brazil (1)
Dan Meyers, MD (1) · Dongyang Liu, MD (1) · Haiyan Liu, MD (1)
PMID 26324329, PMID 29802530, PMID 30609212
2015 (1)