A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)

Browse trials for

• Diabetes Mellitus 10,923
• Diabetes Mellitus, Type 2 9,357

Keywords

• diabetes

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 751 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Study arms

• Experimental
  Omarigliptin

  Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.

  Drug: Omarigliptin · Drug: Glimepiride Placebo · Drug: Metformin · Drug: Insulin Glargine

• Active comparator
  Glimepiride

  Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.

  Drug: Placebo to Omarigliptin · Drug: Glimepiride · Drug: Metformin · Drug: Insulin Glargine

Interventions

• DrugOmarigliptin
• DrugPlacebo to Omarigliptin
• DrugGlimepiride

  Glimepiride (1 mg and/or 2 mg tablets). During the 54-week double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia.

  Also known as: AMARYL®, GLIMY

• DrugGlimepiride Placebo
• DrugMetformin

  Participants will continue on their stable dose (\>=1500 mg/day) of open-label metformin throughout the trial.

• DrugInsulin Glargine

  Insulin glargine can be used for rescue therapy, if glycemic control is not maintained. Insulin therapy should be initiated as per local country insulin glargine label.

Primary outcomes

1. Change From Baseline in Hemoglobin A1C at Week 54

   Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.

   Time frame: Baseline and Week 54

2. Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue

   An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.

   Time frame: Up to Week 57

3. Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue

   Time frame: Up to Week 54

Secondary outcomes

1. Change From Baseline in Fasting Plasma Glucose at Week 54

   Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).

   Time frame: Baseline and Week 54

2. Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54

   The percentage of participants who achieved A1C values \<6.5% (48 mmol/mol) in the FAS Population at Week 54.

   Time frame: Week 54

3. Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue

   Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).

   Time frame: Up to Week 54

4. Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue

   Time frame: Baseline and Week 54

5. Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54

   The percentage of participants who achieved A1C values \<7.0% (53 mmol/mol) in the FAS Population at Week 54.

   Time frame: Week 54

Baseline characteristics

Publications

• Handelsman Y, Lauring B, Gantz I, Iredale C, O'Neill EA, Wei Z, Suryawanshi S, Kaufman KD, Engel SS, Lai E. A randomized, double-blind, non-inferiority trial evaluating the efficacy and safety of omarigliptin, a once-weekly DPP-4 inhibitor, or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy. Curr Med Res Opin. 2017 Oct;33(10):1861-1868. doi: 10.1080/03007995.2017.1335638. Epub 2017 Jun 28. PubMed 28548024 ↗

Individual participant data

Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf