Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00511108
First received: August 2, 2007
Last updated: April 20, 2010
Last verified: April 2010
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Purpose
A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who have inadequate glycemic (blood sugar) control.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus (T2DM) |
Drug: Comparator: sitagliptin phosphate Drug: Comparator: pioglitazone Drug: Comparator: placebo to pioglitazone Drug: Comparator: placebo to sitagliptin |
Phase 1 |
| 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 Phase I Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Study the Safety, Efficacy, and Mechanism of Action of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet and Exercise |
Resource links provided by NLM:
Drug Information available for:
Pioglitazone
Pioglitazone hydrochloride
Sitagliptin
Sitagliptin phosphate
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Change From Baseline in Glucagon 3-hour Total Area Under the Curve (AUC) After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]Glucagon concentration was measured at 9 points during an Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, and 180 minutes. Total AUC was calculated over 3 hours including all sample points starting from 0 minutes using the trapezoid method. The change from baseline reflects Week 12 total AUC minus the Week 0 total AUC.
- Percent Change From Baseline in Index of Static Beta-cell Sensitivity to Glucose After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Static sensitivity is a measure of the effect of glucose on beta cell secretion and is the ratio between the insulin secretion rate and glucose concentration above the threshold level at steady state.
Percent change from baseline was calculated as the difference between index of static sensitivities at Week 12 and at baseline with respect to the index of static sensitivity at baseline times 100.
Secondary Outcome Measures:
- Change From Baseline in Glucose 5-hour Total AUC After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]Glucose concentration was measured at 11 points during an Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, 180, 240, 300 minutes. Total AUC was calculated over 5 hours including all sample points starting from 0 minutes using the trapezoid method. The change from baseline reflects Week 12 total AUC minus the Week 0 total AUC.
| Enrollment: | 211 |
| Study Start Date: | July 2007 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Arm 1: drug
|
Drug: Comparator: sitagliptin phosphate
sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily.
Drug: Comparator: placebo to pioglitazone
pioglitazone 30 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
|
|
Active Comparator: 2
Arm 2: active comparator
|
Drug: Comparator: pioglitazone
pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
Drug: Comparator: placebo to sitagliptin
sitagliptin phosphate 100 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
|
|
Experimental: 3
Arm 3: drug + active comparator
|
Drug: Comparator: sitagliptin phosphate
sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily.
Drug: Comparator: pioglitazone
pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
|
|
Placebo Comparator: 4
Arm 4: placebo comparator
|
Drug: Comparator: placebo to pioglitazone
pioglitazone 30 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
Drug: Comparator: placebo to sitagliptin
sitagliptin phosphate 100 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
|
Eligibility| Ages Eligible for Study: | 30 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient has type 2 diabetes mellitus
- Male
- Female that is highly unlikely to become pregnant
- Patient is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7-10%) or on oral single AHA or low-dose combination therapy (A1C 6.5-9.0%)
Exclusion Criteria:
- Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
- Patient has required insulin therapy within the past 12 weeks
- Patient is on or has been taking a Peroxisome Proliferator-Activated Receptor-gamma (PPAR -gamma) agent (i.e. Thiazolidinediones [TZDs]) within the prior 12 weeks of the screening visit.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00511108 History of Changes |
| Other Study ID Numbers: | 2007_530, MK0431-061 |
| Study First Received: | August 2, 2007 |
| Results First Received: | January 8, 2010 |
| Last Updated: | April 20, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck:
|
Type 2 Diabetes Mellitus (T2DM) |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pioglitazone Sitagliptin |
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 May 23, 2013