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Completed

NCT Number: NCT00902161

A Single-Dose Crossover Study of MK0893 in Patients With Type 2 Diabetes (0893-019 AM4)(COMPLETED)

This study will assess the effect of combined treatment with MK0893 plus propranolol versus placebo plus propranolol on hypoglycemia.

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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

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participant has Type 2 Diabetes (T2DM)
  • Participant is either: Not on an oral antihyperglycemic medication for at least 6 weeks; on a single oral antihyperglycemic medication that is not a peroxisome proliferator-activated gamma (PPAR-gamma) agonist (e.g. Avandia); OR on a combination of no more than two antihyperglycemic medications that are not PPAR-gamma) agonists
  • Participant has not received insulin for at least 6 months
  • Participant has not been treated with a PPAR-gamma agonist for at least 12 weeks
  • Participant has been a nonsmoker for at least 6 months
  • Female participants who are non-pregnant and highly unlikely to conceive due to surgical sterilization, post-menopausal status, not heterosexually active, or willing to use 2 birth control methods

Exclusion criteria

  • Participant has a history of stroke, seizures, or neurological disorders
  • Participant cannot tolerate insulin or propranolol
  • Participant has a history of asthma, emphysema or chronic bronchitis
  • Participant is on a weight loss program that is not in the maintenance phase or has been treated with a weight loss medication within 8 weeks of screening
  • Participant is on or may require treatment with drugs that affect the immune system or with corticosteroids
  • Participant has a history of heart failure or coronary artery disease
  • Participant has a history of uncontrolled high blood pressure
  • Participant is Human Immunodeficiency (HIV), hepatitis B or hepatitis C positive
  • Participant has a history of Type 1 diabetes
  • Participant has a history of hypoglycemia unawareness documented by a blood glucose concentration < 55 mg/dL (3.1 mol/L) without symptoms of hypoglycemia.

Treatment and study plan

MK0893

Drug

Single dose of MK0893 1000 mg (ten 100 mg tablets)

MK0893-matched Placebo

Drug

Single dose of placebo to MK0893 (ten tablets)

Propranolol Hydrochloride (HCL)

Drug

Propranolol tablets titrated up to 80 mg three times daily over a four week period. Total treatment was approximately 7 weeks.

Primary outcomes

  1. Recovery Time (Rt[65] From Insulin-induced Hypoglycemia

    Time frame: From the time of hypoglycemic clamp (t=0 minutes) through 270 minutes

    Rt(65) defined as the time to recover from hypoglycemia (blood glucose level of 50 mg/dL) to an arterialized venous blood glucose of 65 mg/dL. At t= -60 minutes on the morning of Day 1 (Visit 6) or Day 22 (Visit 8), a hypoglycemic clamp was used via an increased insulin infusion rate to achieve blood glucose concentrations of 50 mg/dL (2.8 mmol/L) within ~30-90 minutes. At the end of the 30-minute hypoglycemic clamp interval, insulin and glucose infusions were terminated, and the time to recover from hypoglycemia to 65 mg/dL Rt(65) was determined. Rt(65) was followed up to 270 minutes

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax) and Concentration Average Over 8-12 Hours (C[Ave] 8-12 hr) Post Single Dose MK0893

    Time frame: From time of MK0893 administration through 24 hours post-dose

    Cmax was the maximum or "peak" concentration of MK0893 observed after its administration.

    Approximate C(ave 8-12) was the MK0893 concentration average over 8-12 hours post-dose and was computed as the Area Under the Curve over 8-12 hours post-dose (AUC [8-12]) ÷ 4

  2. Plasma Concentration at 32 Hours (C[32hr]) Post Single Dose MK0893

    Time frame: From time of MK0893 administration through estimated 32 hours post-dose

    Plasma concentration of single dose MK0893 was measured from time of administration to 24 hours post-dose and extrapolated out to 32 hours post-dose using the plasma concentration vs. time curve

  3. Number of Participants With An Adverse Event (AE)

    Time frame: From time of administration of study treatment through end of Post-Study (up to 21 days after administration of last dose of study treatment).

    An AE was defined as any unfavorable and unintended change in the

    structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. This also included any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product.

  4. Number of Participants Who Discontinued Study Treatment Due To AEs

    Time frame: From time of first administration of study treatment to time of last administration of study treatment (up to Day 21)

    An AE was defined as any unfavorable and unintended change in the

    structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. This also included any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Double-Blind, Randomized, Placebo-Controlled, Single-Dose Crossover Study to Assess the Safety and Tolerability of MK0893 Coadministered With Propranolol Hydrochloride in Patients With Type 2 Diabetes

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 15, 2009
Registry last updated
Jul 3, 2015

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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