A Study of Different Doses of Sitagliptin (MK-0431) in Participants With Type 2 Diabetes Mellitus (MK-0431-014)

Type II Diabetes Mellitus Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Finding Study of Once-Daily Dosing of Sitaglipin (MK-0431) in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00481663
• Other study ID #: 0431-014
• Secondary ID: 2007_570
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2007
• Last updated: March 31, 2017
• Start date: August 19, 2003
• Est. completion date: May 14, 2006

Study information

• Verified date: March 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study of different doses of MK-0431 in participants with type 2 diabetes mellitus. There have been 3 extensions to the base study (Extension 1: up to Week 52, Extension 2: up to Week 106, and Extension 3: up to Week 158). The primary hypothesis for the study is that In participants with type 2 diabetes who have inadequate glycemic control, after 12 weeks of treatment, a dose-response will be seen across once-daily doses of MK-0431 in lowering hemoglobin A1C (HbA1c).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 555
• Est. completion date: May 14, 2006
• Est. primary completion date: July 21, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Men and non-pregnant women

• Fasting plasma glucose >= 130 mg/dL

• HbA1c >=6.5% and >10.0%

Exclusion Criteria:

• You have a history of type I diabetes

• You are on a weight loss program with ongoing weight loss or taking weight loss medication

• You have had surgery within 30 days

• You hvae hepatitis B or C.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type II Diabetes Mellitus

Intervention

Drug:
• Sitagliptin

• Placebo to sitagliptin

• Metformin

• Rescue
Patients whose FPG >240 mg/dL from Week 16 or HbA1C >8.5% from Week 25 up to (not including) Week 52 could receive rescue antihyperglycemic therapy with pioglitazone, and remain in the extension study (Extension 1). Participants were eligible for rescue with pioglitazone 30 mg (or rosiglitazone in countries where pioglitazone was not licensed) if they met the following criteria: from Week 16 and during the second extension: FPG consistently >240 mg/dL (repeated and confirmed within 3 to 7 days); from Week 52 up to (not including) Week 70: HbA1C >8%; from Week 70 up to (not including) Visit 21/Week 106: HbA1C >7.5% (Extension 2). Participants placed on rescue therapy with pioglitazone (rosiglitazone where pioglitazone is not available) in the first or second extensions were not eligible for enrollment in the third extension. Rescue therapy was not available in the third extension.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Hanefeld M, Herman GA, Wu M, Mickel C, Sanchez M, Stein PP; Sitagliptin Study 014 Investigators.. Once-daily sitagliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of patients with type 2 diabetes. Curr Med Res Opin. 2007 Jun;23(6):1329-39. Epub 2007 Apr 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in HbA1C at Week 12		Baseline and Week 12
Primary	Number of Participants Who Experienced One or More Adverse Events (AE) up to Week 14		Up to Week 14
Primary	Number of Participants Who Experienced One or More AE up to Week 54		Up to Week 54
Primary	Number of Participants Who Experienced One or More AE up to Week 108		Up to Week 108
Primary	Number of Participants Who Experienced One or More AE up to Week 160		Up to Week 160
Primary	Number of participants Who Discontinued Study Treatment Due to An AE up to Week 12		Up to Week 12
Primary	Number of participants Who Discontinued Study Treatment Due to An AE up to Week 52		Up to Week 52
Primary	Number of participants Who Discontinued Study Treatment Due to An AE up to Week 106		Up to Week 106
Primary	Number of participants Who Discontinued Study Treatment Due to An AE up to Week 158		Up to Week 158
Secondary	Change from Baseline in HbA1C at Week 52		Baseline and Week 52
Secondary	Change from Baseline in HbA1C at Week 106		Baseline and Week 106
Secondary	Change from Baseline in HbA1C at Week 158		Baseline and Week 158
Secondary	Change from Baseline in Fasting Plasma Glucose (FPG) at Week 12		Baseline and Week 12
Secondary	Change from Baseline in FPG at Week 52		Baseline and Week 52
Secondary	Change from Baseline in FPG at Week 106		Baseline and Week 106
Secondary	Change from Baseline in FPG at Week 158		Baseline and Week 158
Secondary	Change from Baseline in Body Weight at Week 12		Baseline and Week 12
Secondary	Change from Baseline in Body Weight at Week 52		Baseline and Week 52
Secondary	Change from Baseline in Body Weight at Week 106		Baseline and Week 106
Secondary	Change from Baseline in Body Weight at Week 158		Baseline and Week 158
Secondary	Change From Baseline in Serum Fructosamine at Week 12		Baseline and Week 12
Secondary	Change From Baseline in Daily Seven-Point Fingerstick Glucose Average at Week 12		Baseline and Week 12
Secondary	Change From Baseline in Daily Seven-Point Fingerstick Glucose Average at Week 52		Baseline and Week 52