Clinical trial NCT02004886: A Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Participants With Type 2 Diabetes Mellitus (MK-0893-005)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 74
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Not currently on antihyperglycemic agent (AHA) or AHA monotherapy (not to include treatment with insulin or thiazolidinediones \[i.e., peroxisome proliferator activated receptor-gamma, PPARγ agents\])
* 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

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

Primary outcomes:
measure: Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4
timeFrame: Baseline and Week 4
measure: Number of Participants Experiencing an Adverse Event (AE)
timeFrame: Up to 42 days
measure: Number of Participants Discontinuing Study Treatment Due to an AE
timeFrame: Up to 28 days
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG)
timeFrame: Baseline and Week 4
measure: Change From Baseline in Fructosamine at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Fasting C-peptide at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Fasting Insulin at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in 2-hour Post-prandial Glucose Excursion at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in 3-hour Area Under the Plasma Concentration Versus Time Curve (AUC) for Glucose at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in 3-hour AUC for C-peptide at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in 3-hour Insulin Total AUC at Week 4
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
Study officials:
References: