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Completed

NCT Number: 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)

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.

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Key information

Conditions

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

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-0893

Drug

10 mg and 100 mg tablets

metformin

Drug

500 mg metformin tablets

Other names: Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet

Placebo

Drug

Placebo tablets matching MK-0893

Primary outcomes

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

    Time frame: Baseline and 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.

  2. Number of Participants Experiencing an Adverse Event (AE)

    Time frame: Up to 42 days

    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.

  3. Number of Participants Discontinuing Study Treatment Due to an AE

    Time frame: Up to 28 days

    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.

Secondary outcomes

  1. Change From Baseline in Fasting Plasma Glucose (FPG)

    Time frame: Baseline and Week 4

    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.

  2. Change From Baseline in Fructosamine at Week 4

    Time frame: Baseline and 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.

  3. Change From Baseline in Fasting C-peptide at Week 4

    Time frame: Baseline and 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.

  4. Change From Baseline in Fasting Insulin at Week 4

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

  6. Change From Baseline in 3-hour Area Under the Plasma Concentration Versus Time Curve (AUC) for Glucose at Week 4

    Time frame: Baseline and 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.

  7. Change From Baseline in 3-hour AUC for C-peptide at Week 4

    Time frame: Baseline and 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.

  8. Change From Baseline in 3-hour Insulin Total AUC at Week 4

    Time frame: Baseline and 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 9, 2013
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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