A Study to Test MK-0941 in Adults With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0941-018)

Merck Sharp & Dohme LLC68 enrolled

Overview

The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking insulin for Type 2 Diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

MK-0941DRUG

MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose.

PlaceboDRUG

Placebo tablets, taken 3 times daily.

InsulinDRUG

Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant has Type 2 Diabetes Mellitus Exclusion Criteria: * Participant has a history of Type 1 Diabetes Mellitus or ketoacidosis * Participant is on a weight loss program and is not in the maintenance phase or is taking a weight loss medication * Participant has had surgery within 30 days of starting the study or has planned major surgery

Outcomes

Primary Outcomes

Change From Baseline in Hemoglobin A1c (HbA1c) Level

HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels.

Time frame: Baseline (Day 1) and End of Treatment (Week 20)

Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)

Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy.

Time frame: From first dose of study drug (Week 0) to last dose of study drug (Week 20)

Data from ClinicalTrials.gov

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