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Phase 1 N=10 Randomized Double-blind Treatment

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

Type 2 Diabetes Mellitus

Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Recovery Time From Hypoglycemia to Euglycemia — 74.49; 88.90; 109.81 Minutes

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Placebo (Drug); Glimepiride 2 mg (Drug); Glimepiride 4 mg (Drug); Hypoglycemic Clamp (Procedure)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Merck Sharp & Dohme LLC
Primary completion
Jan 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Recovery Time From Hypoglycemia to Euglycemia
74.49; 88.90; 109.81
PRIMARY
Rate of Recovery From Hypoglycemia to Euglycemia
0.32; 0.22; 0.19
PRIMARY
Incremental Weighted Average Blood Glucose Concentration Over 3 Hours of Hypoglycemic Recovery
22.61; 17.58; 15.34

Summary

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.

Eligibility Criteria

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) = = 7% and = 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01614769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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