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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Multi-Center, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Panel Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02004886
• Other study ID #: 0893-005
• Status: Completed
• Phase: Phase 2
• Start date: August 11, 2006
• Est. completion date: February 7, 2007

Study information

• Verified date: August 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 7, 2007
• Est. primary completion date: February 7, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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, PPAR? 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• MK-0893
10 mg and 100 mg tablets
• Metformin
500 mg metformin tablets
• Placebo
Placebo tablets matching MK-0893
• Placebo
Placebo tablets matching metformin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change From Baseline in Fasting Plasma Glucose (FPG)	Plasma Glucose levels were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.	Baseline and Week 4
Secondary	Change From Baseline in Fructosamine at Week 4	Fructosamine levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.	Baseline and Week 4
Secondary	Change From Baseline in Fasting C-peptide at Week 4	Fasting C-peptide levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.	Baseline and Week 4
Secondary	Change From Baseline in Fasting Insulin at Week 4	Fasting insulin levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.	Baseline and Week 4
Secondary	Change From Baseline in 2-hour Post-prandial Glucose Excursion at Week 4	2-hour post-prandial glucose excursion is the change in glucose concentration in the blood 2 hours after a meal. Change from baseline in 2-hour post-prandial glucose excursion at Week 4 is defined as Week 4 minus baseline.	Baseline and Week 4
Secondary	Change From Baseline in 3-hour Area Under the Plasma Concentration Versus Time Curve (AUC) for Glucose at Week 4	Blood samples collected for glucose 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for Glucose was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.	Baseline and Week 4
Secondary	Change From Baseline in 3-hour AUC for C-peptide at Week 4	Blood samples were collected for C-peptide 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for C-peptide was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.	Baseline and Week 4
Secondary	Change From Baseline in 3-hour Insulin Total AUC at Week 4	Blood samples were collected for insulin 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour Insulin Total AUC was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.	Baseline and Week 4