A Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Participants With Type 2 Diabetes Mellitus (MK-0893-005)

NCT02004886 | Completed Phase 2 Results

• 1 other identifier: 0893-005
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in participants with type 2 diabetes mellitus. The primary hypothesis is that MK-0893 will reduce 24-hour weighted mean glucose (WMG) significantly more than placebo.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Therapeutic Uses; Pharmacologic Actions; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Metformin

Outcome Measures

Primary Outcomes (3)

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

  Blood samples were collected 30 minutes prior to all meals, and 15, 30, 60, 90, 120, 180 minutes post-meal, then and at midnight, 3 AM, and the next morning at 6:30 AM and 7:30 AM. A 24-hour weighted mean glucose (WMG) was determined by averaging multiple plasma glucose measurements over a 24-hour period.

  Baseline and Week 4

• Number of Participants Experiencing an Adverse Event (AE)

  An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.

  Up to 42 days

• Number of Participants Discontinuing Study Treatment Due to an AE

  An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.

  Up to 28 days

Secondary Outcomes (8)

• Change From Baseline in Fasting Plasma Glucose (FPG)

  Baseline and Week 4

• Change From Baseline in Fructosamine at Week 4

  Baseline and Week 4

• Change From Baseline in Fasting C-peptide at Week 4

  Baseline and Week 4

• Change From Baseline in Fasting Insulin at Week 4

  Baseline and Week 4

• Change From Baseline in 2-hour Post-prandial Glucose Excursion at Week 4

  Baseline and Week 4

Study Arms (4)

MK-0893 (40 mg)

EXPERIMENTAL

MK-0893 40-mg q.d. (quaque die, once daily) group will receive MK-0893 40-mg tablets (after loading dose with 160 mg) and matching placebo to metformin and matching placebo to MK-0893.

Drug: MK-0893; Drug: Placebo

MK-0893 (120 mg)

EXPERIMENTAL

MK-0893 at 120 mg q.d. group will receive MK-0893 120 mg q.d. tablets (after loading dose of 500 mg on Day 1) and matching placebo tablets to metformin and matching placebo to MK-0893

Drug: MK-0893; Drug: Placebo

Metformin (2000 mg)

ACTIVE COMPARATOR

Metformin taken orally, 500 mg tablets, Day 1 to Day 6: 500 mg b.i.d. (bis in die, twice daily), Day 7 to Day 13: 1000 mg in the morning and 500 mg in the evening, and Day 14 to Day 28: 1000 mg. b.i.d. and matching placebo to MK-0893.

Drug: Metformin; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo tablets matching the MK-0893 and placebo tablets matching metformin.

Drug: Placebo

Interventions

MK-0893 DRUG

10 mg and 100 mg tablets

MK-0893 (120 mg); MK-0893 (40 mg)

Metformin DRUG

500 mg metformin tablets

Also known as: Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet

Metformin (2000 mg)

Placebo DRUG

Placebo tablets matching MK-0893

MK-0893 (120 mg); MK-0893 (40 mg); Metformin (2000 mg); Placebo

Eligibility Criteria

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

You may qualify if:

• Type 2 diabetes
• Not currently on antihyperglycemic agent (AHA) or AHA monotherapy (not to include treatment with insulin or thiazolidinediones \[i.e., peroxisome proliferator activated receptor-gamma, PPARγ agents\])
• male or a female of non-childbearing potential. Women must be postmenopausal or premenopausal and documented surgically sterilized
• A body mass index (BMI) that is \> 20 and ≤ 40 kg/m2

You may not qualify if:

• History of type 1 diabetes or assessed by the investigator as possibly having type 1 diabetes
• History of ketoacidosis; clinically unstable or rapidly progressive diabetic retinopathy, nephropathy, neuropathy
• Treatment for diabetes within 3 months of study participation with combination anti-hyperglycemic therapy, insulin or thiazolidinediones (e.g., rosiglitazone or pioglitazone)
• oral corticosteroid medications within 2 weeks prior to study participation, or requires digoxin, warfarin, warfarin-like anticoagulants, theophylline, anti-dysrhythmic or anti-seizure medications, immunosuppressants, or anti-neoplastic agents, or herbal remedies
• History of acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV)
• History of gastrointestinal problems or disorders or extensive bowel or gastric surgery
• History of significant or unstable cardiovascular disease
• History of neoplastic disease
• History of hepatic disease
• History of seizures, epilepsy or other neurologic disease
• History of myelodysplastic or pre-leukemic disorders or other severe hematological disorder

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Interventions

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

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

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: December 3, 2013
• First Posted: December 9, 2013
• Study Start: August 11, 2006
• Primary Completion: February 7, 2007
• Study Completion: February 7, 2007
• Last Updated: September 5, 2018
• Results First Posted: March 18, 2014

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share