A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)

NCT00631488 | Completed Phase 2 Results

• 2 other identifiers: 0893-0152007_646
• Study Type: interventional
• Target: 146
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will test the effectiveness and safety of treatment with MK-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels

  BL, 4 weeks (end of double-blind treatment period)

Secondary Outcomes (4)

• Change From BL to Week 4 in Fasting Plasma Glucose (FPG)

  BL, 4 weeks (end of double-blind treatment period)

• Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)

  BL, 4 weeks (end of double-blind treatment period)

• Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC

  BL, 4 weeks (end of double-blind treatment period)

• Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC

  BL, 4 weeks (end of double-blind treatment period)

Study Arms (3)

MK-0893 + Sitagliptin

EXPERIMENTAL

Drug: MK-0893; Drug: Sitagliptin; Drug: Placebo for Metformin

MK-0893 + Metformin

EXPERIMENTAL

Drug: MK-0893; Drug: Metformin; Drug: Placebo for Sitagliptin

Sitagliptin + Metformin

ACTIVE COMPARATOR

Drug: Sitagliptin; Drug: Metformin; Drug: Placebo for MK-0893

Interventions

MK-0893 DRUG

Initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period (4 weeks).

MK-0893 + Metformin; MK-0893 + Sitagliptin

Sitagliptin DRUG

Sitagliptin Phosphate administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).

Also known as: JANUVIA™, MK0431

MK-0893 + Sitagliptin; Sitagliptin + Metformin

Metformin DRUG

Metformin taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin then administered throughout the double-blind treatment period (4 weeks).

Also known as: GLUCOPHAGE®

MK-0893 + Metformin; Sitagliptin + Metformin

Placebo for MK-0893 DRUG

Matching placebo for MK-0893 was orally administered for the loading dose (200 mg) and for the following daily treatment (40 mg) over the 4 week double blind treatment period.

Sitagliptin + Metformin

Placebo for Sitagliptin DRUG

Matching placebo for Sitagliptin (100 mg) administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).

MK-0893 + Metformin

Placebo for Metformin DRUG

Metformin-matched placebo taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin-matched placebo then administered throughout the double-blind treatment period (4 weeks).

MK-0893 + Sitagliptin

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy

You may not qualify if:

• Participants have a history of Type 1 Diabetes Mellitus
• Participants taking insulin or thiazolidinediones (TZDs: peroxisome proliferator-activated receptor \[PPAR\]-gamma agonists)
• Participants who have a contraindication to metformin or sitagliptin

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

N-((4-(1-(3-(3,5-dichlorophenyl)-5-(6-methoxynaphthalen-2-yl)-1H-pyrazol-1-yl)ethyl)phenyl)carbonyl)-beta-alanine; Sitagliptin Phosphate; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: March 7, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: January 2, 2017
• Results First Posted: February 17, 2012

Record last verified: 2016-12