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Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus (MK-0000-253)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01614769
First received: June 6, 2012
Last updated: July 1, 2014
Last verified: July 2014

June 6, 2012
July 1, 2014
July 2012
January 2013   (final data collection date for primary outcome measure)
  • Recovery Time From Hypoglycemia to Euglycemia [ Time Frame: From 1 to 180 minutes post hypoglycemic clamp ] [ Designated as safety issue: Yes ]
    Immediately after release of the hypoglycemic clamp, which maintained blood glucose close to 50 mg/dL, the time taken until glucose reached euglycemia, defined as 3 consecutive measurements >= 70 mg/dL, is called the recovery time.
  • Rate of Recovery From Hypoglycemia to Euglycemia [ Time Frame: From 1 to 180 minutes post hypoglycemic clamp ] [ Designated as safety issue: Yes ]
    The rate of recovery is the difference in concentration between blood glucose at euglycemia and at the end of the hypoglycemic clamp, divided by the recovery time.
  • Incremental Weighted Average Blood Glucose Concentration Over 3 Hours of Hypoglycemic Recovery [ Time Frame: From 1 to 180 minutes post hypoglycemic clamp ] [ Designated as safety issue: Yes ]
    The incremental weighted average qualitatively assesses overall hypoglycemic recovery by measuring mean glycemia over the 3 hour recovery period. Blood glucose measured at the release of the hypoglycemic clamp, considered the baseline value, was subtracted from blood glucose values measured over the ensuing 3 hours of hypoglycemic recovery. These differences from baseline were averaged to calculate the incremental weighted average blood glucose concentration.
  • Recovery time from hypoglycemia to euglycemia [ Time Frame: From 1 to 180 minutes post hypoglycemic clamp ] [ Designated as safety issue: Yes ]
  • Rate of recovery from hypoglycemia to euglycemia [ Time Frame: From 1 to 180 minutes post hypoglycemic clamp ] [ Designated as safety issue: Yes ]
  • Incremental weighted average blood glucose concentration over 3 hours of hypoglycemic recovery [ Time Frame: From 1 to 180 minutes post hypoglycemic clamp ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01614769 on ClinicalTrials.gov Archive Site
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Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus (MK-0000-253)
A Study to Assess the Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus

This study aims to assess how glimepiride affects the recovery from hypoglycemia in participants with type 2 diabetes mellitus. The primary objective is to estimate the time taken by participants to recover from hypoglycemia to euglycemia after treatment with either 2 mg or 4 mg of glimepiride when compared to placebo.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Placebo
    Two gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods.
  • Drug: Glimepiride 2 mg
    One placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods.
  • Drug: Glimepiride 4 mg
    Two 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods.
  • Procedure: Hypoglycemic Clamp
    On Day 1 of the three treatment periods, 180 minutes after drug treatment, a fixed-rate insulin infusion is combined with a variable-rate dextrose infusion to maintain plasma glucose concentrations at close to 50 mg/dL for 30 minutes.
  • Experimental: Placebo → Glimepiride 2 mg → Glimepiride 4 mg
    Participants received placebo in the first period, 2 mg glimepiride in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.
    Interventions:
    • Drug: Placebo
    • Drug: Glimepiride 2 mg
    • Drug: Glimepiride 4 mg
    • Procedure: Hypoglycemic Clamp
  • Experimental: Glimepiride 2 mg → Glimepiride 4 mg → Placebo
    Participants received 2 mg glimepiride in the first period, 4 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.
    Interventions:
    • Drug: Placebo
    • Drug: Glimepiride 2 mg
    • Drug: Glimepiride 4 mg
    • Procedure: Hypoglycemic Clamp
  • Experimental: Glimepiride 4 mg → Placebo → Glimepiride 2 mg
    Participants received 4 mg glimepiride in the first period, placebo in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.
    Interventions:
    • Drug: Placebo
    • Drug: Glimepiride 2 mg
    • Drug: Glimepiride 4 mg
    • Procedure: Hypoglycemic Clamp
  • Experimental: Placebo → Glimepiride 4 mg → Glimepiride 2 mg
    Participants received placebo in the first period, 4 mg glimepiride in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.
    Interventions:
    • Drug: Placebo
    • Drug: Glimepiride 2 mg
    • Drug: Glimepiride 4 mg
    • Procedure: Hypoglycemic Clamp
  • Experimental: Glimepiride 2 mg → Placebo → Glimepiride 4 mg
    Participants received 2 mg glimepiride in the first period, placebo in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.
    Interventions:
    • Drug: Placebo
    • Drug: Glimepiride 2 mg
    • Drug: Glimepiride 4 mg
    • Procedure: Hypoglycemic Clamp
  • Experimental: Glimepiride 4 mg → Glimepiride 2 mg → Placebo
    Participants received 4 mg glimepiride in the first period, 2 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.
    Interventions:
    • Drug: Placebo
    • Drug: Glimepiride 2 mg
    • Drug: Glimepiride 4 mg
    • Procedure: Hypoglycemic Clamp
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has clinically confirmed diagnosis of type 2 diabetes mellitus (T2DM) controlled by diet and exercise alone, or treated by metformin only with same dose for >= 12 weeks prior to screening visit.
  • Females of reproductive potential who demonstrate nongravid state, agree to use (and/or have partner use) two acceptable methods of birth control starting at least two weeks prior to study, throughout study, and at least two weeks after last dose of study drug.
  • Females of non-reproductive potential, post menopausal, status post hysterectomy, oophorectomy or tubal ligation.
  • Is in good health, other than T2DM.
  • Has been a nonsmoker and/or non user of nicotine-containing products for the previous 6 months. If discontinued use for previous 3 months, may be enrolled at investigator's discretion.
  • Will follow American Heart Association weight maintaining diet and exercise program or equivalent beginning 2 weeks prior to study until poststudy visit.
  • At screening visit has a Body Mass Index (BMI) =< 40 kg/m^2.
  • At screening visit has a Hemoglobin A1c (HbA1c) of >= 7% and < 10% (+/- 0.1%).
  • On the morning of randomization at predose has fasting plasma glucose (FPG) >= 126 mg/dL, and =< 250 mg/dL.

Exclusion Criteria:

  • Has a history of stroke, chronic seizures, or major neurological disorder.
  • Has a history of any illness that might confound the results of the study or pose additional risk to the participant.
  • Has a history of type 1 diabetes mellitus, ketoacidosis, C-peptide =< 0.8 ng/mL, secondary forms of diabetes or diabetic complications.
  • Has a history of neoplastic disease.
  • Is a nursing mother.
  • Has been treated =< one year of screening visit with sulfonylurea agents, meglitinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) analogs, or insulin.
  • Has received treatment within =< 12 weeks of screening visit with a peroxisome proliferator-activated receptor γ (PPARγ) agonist.
  • Is taking medications for a co-morbid condition or anticipates taking new medications beginning 2 weeks prior to study.
  • Consumes excessive amounts of alcohol or caffeinated beverages.
  • Is a regular user of illicit drugs, or has a history of drug abuse within the previous 6 months.
  • Has had major surgery, lost 500 mL of blood, or participated in another investigational study within 4 weeks prior to screening visit.
  • Is on a weight loss program, but not in the maintenance phase, or treated with a weight loss medication within 8 weeks of prestudy visit.
  • Has a history of severe allergies, anaphylactic reaction or intolerability to drugs, food, insulin, glimepiride or sulfonamide derivatives.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01614769
0000-253
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP