Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00337610
First received: June 14, 2006
Last updated: May 27, 2010
Last verified: May 2010
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Purpose
A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus (T2DM) |
Drug: sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day Drug: comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Change From Baseline in A1C at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Secondary Outcome Measures:
- Change From Baseline in FPG at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.
- Change From Baseline in 2 Hr-PMG at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]Change from baseline at Week 18 is defined as Week 18 minus Week 0.
- Change From Baseline in A1C at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: No ]A1C was measured as a percent. Thus, this change from baseline reflects the Week 30 A1C percent minus the Week 0 A1C percent.
| Enrollment: | 190 |
| Study Start Date: | June 2006 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: sitagliptin 100 mg once a day (q.d.)/metformin ≥1500 mg a day |
Drug: sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day
Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.
Other Name: Januvia
|
| Placebo Comparator: sitagliptin 100 mg placebo q.d./ metformin ≥ 1500 mg/day |
Drug: comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day
Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.
|
Eligibility| Ages Eligible for Study: | 18 Years to 78 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient has type 2 diabetes mellitus
- Males
- Females who are highly unlikely to become pregnant
- Patients poorly controlled while taking one or two oral antidiabetic medications
Exclusion Criteria:
- Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
- Patient required insulin therapy within the prior 8 weeks
- Patient is on or has been taking Thiazolidinediones (TZDs) such as Actos® (pioglitazone) or Avandia® (rosiglitazone) or is on or has been taking Byetta® (exenatide) within the prior 12 weeks of the screening visit
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00337610 History of Changes |
| Other Study ID Numbers: | 2006_017, MK0431-053 |
| Study First Received: | June 14, 2006 |
| Results First Received: | September 24, 2009 |
| Last Updated: | May 27, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sitagliptin Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013