A Study to Evaluate ITCA 650 Compared to Glimepiride as Add on Therapy for the Treatment of Type 2 Diabetes
NCT01455922 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2012-12-25
Summary
Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.
Conditions
Interventions
- DRUG
-
ITCA 650
ITCA 650 is exenatide in DUROS
- DRUG
-
glimepiride
glimepiride will be up-titrated to 8 mg/day over first 13 weeks
Sponsors & Collaborators
-
Intarcia Therapeutics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-02-28
- Primary Completion
- 2014-07-31
- Completion
- 2014-07-31
Countries
- United States
Study Locations
More Related Trials
-
Early Intermittent Intensive Insulin Therapy as an Effective Treatment of Type 2 Diabetes (RESET-IT Main Trial)
NCT02192424 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetics
NCT00698230 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes
NCT01885260 ·Status: COMPLETED ·Phase: PHASE2
-
Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus (MK-0000-253)
NCT01614769 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Linagliptin in Comparison With Glimepiride as Add on to Metformin on Postprandial Beta Cell Function, Postprandial Metabolism and Oxidative Stress in Patients With Type 2 Diabetes Mellitus
NCT01547104 ·Status: UNKNOWN ·Phase: PHASE4
-
Dose Proportionality Study Comparing Amaryl-M 1/500 mg and Amaryl-M 2/500 mg
NCT00934817 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 Diabetes
NCT02583919 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus
NCT01644500 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono-therapy in Chinese Type 2 Diabetes Mellitus (T2DM)
NCT00908921 ·Status: COMPLETED ·Phase: PHASE4
-
Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide
NCT00279045 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients
NCT01708902 ·Status: COMPLETED ·Phase: PHASE3
-
Phase III Trial to Evaluate the Efficacy and Safety of Gemigliptin 50mg qd Added to Ongoing Glimepiride as Fix-dose Combination in Patients With Type 2 Diabetes
NCT02089126 ·Status: UNKNOWN ·Phase: PHASE3
-
Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT00614120 ·Status: COMPLETED ·Phase: PHASE3
-
Study Comparing Efficacy and Safety of Amaryl M and Metformin Uptitraion to Type 2 DM
NCT00612144 ·Status: COMPLETED ·Phase: PHASE4
-
Long-term Efficacy and Safety of HMS5552 add-on to Metformin in T2DM Subjects
NCT03141073 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled
NCT01699932 ·Status: COMPLETED ·Phase: PHASE3
-
Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022)
NCT01704261 ·Status: COMPLETED ·Phase: PHASE3
-
Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid
NCT00915772 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy/Safety Study of Glimepiride to Type 2 Diabetes Patients Based on Metformin And Basal Insulin Treatment
NCT02026310 ·Status: COMPLETED ·Phase: NA
-
A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)
NCT01682759 ·Status: COMPLETED ·Phase: PHASE3
-
Dual Add-on Therapy in Type 2 Diabetes Poorly Controlled With Metformin Monotherapy
NCT04667143 ·Status: UNKNOWN ·Phase: PHASE3
-
Phase III Study for Glimepiride + Metformin Hydrochloride (Amaryl M) Slow Release (SR)
NCT00437554 ·Status: COMPLETED ·Phase: PHASE3
-
A Study in Patients With Type 2 Diabetes
NCT01408095 ·Status: WITHDRAWN ·Phase: PHASE2
-
Bioequivalence and Drug - Drug Interaction Study of Metformin/Gliclazide in Healthy Participants
NCT03467945 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerance and Activity of HE3286 in Patients With Type 2 Diabetes Mellitus
NCT00694057 ·Status: COMPLETED ·Phase: PHASE2