Study of Sitagliptin for the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0431-260) | RxWiki

Study of Sitagliptin for the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0431-260)

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to examine the insulin-sparing effect of sitagliptin 100 mg once-daily compared with placebo over 24 weeks in participants with type 2 diabetes mellitus who have inadequate glycemic control on insulin alone or in combination with metformin. The primary hypothesis of this study is that after 24 weeks, sitagliptin reduces the dose of insulin relative to placebo.
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Sitagliptin Drug: Comparator: Placebo Biological: Insulin Glargine Drug: Metformin
Phase	Phase 3
Sponsor	Merck Sharp & Dohme Corp.
Responsible Party	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier	NCT01462266
First Received	October 27, 2011
Last Updated	March 7, 2014
Last verified	March 2014

Tracking Information[ + expand ][ + ]

First Received Date	October 27, 2011
Last Updated Date	March 7, 2014
Start Date	January 2012
Estimated Primary Completion Date	June 2013
Current Primary Outcome Measures	Change From Baseline in Daily Insulin Dose at Week 24 [Time Frame: Baseline and Week 24] [Designated as safety issue: No]Change in daily insulin dose following 24 weeks of therapy (i.e., daily insulin dose at Week 24 minus daily insulin dose at baseline)
Current Secondary Outcome Measures	Change From Baseline in Hemoglobin A1c (A1C) at Week 24 [Time Frame: Baseline and Week 24] [Designated as safety issue: No]A1C is measured as the percentage of glycosylated hemoglobin. Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline) Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [Time Frame: Baseline and Week 24] [Designated as safety issue: No]Change in FPG (before breakfast) following 24 weeks of therapy (i.e., FPG at Week 24 minus FPG at baseline) Percent of Participants Achieving Fasting Glucose Target at Any Time During the Study [Time Frame: Up to 24 weeks] [Designated as safety issue: No]The fasting glucose target was defined as 3 consecutive days with a fingerstick glucose of 72 to 100 mg/dL (4.0 - 5.6 mmol/L). Time to Achieve the Fasting Glucose Target [Time Frame: Up to 24 weeks] [Designated as safety issue: No]Fasting glucose target 3 consecutive days with a fingerstick glucose of 72 to 100 mg/dL (4.0 - 5.6 mmol/L). This analysis was the Kaplan-Meier estimated 50th percentile of time (days) to first attainment of target.

Descriptive Information[ + expand ][ + ]

Brief Title	Study of Sitagliptin for the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0431-260)
Official Title	A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Safety and Insulin-Sparing Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Alone or in Combination With Metformin
Brief Summary	The purpose of this study is to examine the insulin-sparing effect of sitagliptin 100 mg once-daily compared with placebo over 24 weeks in participants with type 2 diabetes mellitus who have inadequate glycemic control on insulin alone or in combination with metformin. The primary hypothesis of this study is that after 24 weeks, sitagliptin reduces the dose of insulin relative to placebo.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Sitagliptin Sitagliptin 100 mg tablet once daily for 24 weeks Other Names: JanuviaDrug: Comparator: Placebo Placebo to sitagliptin once daily for 24 weeks Biological: Insulin Glargine Participants on insulin glargine or another insulin regimen for at least 10 weeks prior to screening will continue or switch to open-label insulin glargine once-daily in the evening for the duration of the study. Drug: Metformin Participants on metformin oral tablet(s) at a dose of at least 1500 mg/day for at least 10 weeks prior to screening will continue receiving metformin at their current dose for the duration of the study. Other Names: Glucophage
Study Arm (s)	Experimental: Sitagliptin Sitagliptin 100 mg once daily Placebo Comparator: Placebo Placebo to sitagliptin once daily

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	660
Estimated Completion Date	June 2013
Estimated Primary Completion Date	June 2013
Eligibility Criteria	Inclusion Criteria: - has type 2 diabetes mellitus - has one of the following criteria: - diagnosed with diabetes after age 40 years and insulin therapy was initiated at least 3 years following diagnosis - if diagnosed with diabetes under age 40 years or insulin started earlier than 3 years after diagnosis, has a fasting C-peptide greater than 0.7 ng/mL - must be at least 18 years of age and less than or equal to 80 years of age (for participants in India: must be at least 18 years of age and less than or equal to 65 years of age) - on a stable regimen of insulin for at least 10 weeks with or without metformin (at least 1500 mg/day) and/or sulfonylurea for at least 10 weeks - is highly unlikely to become pregnant (not of reproductive potential or agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control during the study and for 14 days after the last dose of study medication Exclusion Criteria: - has been treated with a dipeptidyl peptidase IV (DPP-4) inhibitor, a thiazolidinedione (TZD), or a glucagon-like peptide-1 (GLP-1) mimetic or analogue, within the past 12 weeks - currently on treatment with daily use (one or more injections per day) of a pre-prandial short-acting or rapid-acting insulin alone or as part of a basal/bolus insulin regimen - has symptomatic hyperglycemia that requires immediate initiation, adjustment, or addition of antihyperglycemic therapy - has a history of 2 or more episodes of hypoglycemia resulting in seizure, coma, or loss of consciousness, - or - has had recurrent (≥3 times per week) episodes of hypoglycemia over the past 8 weeks - has a history of ketoacidosis - is not appropriate for or does not agree to target a fasting glucose of 72-100 mg/dL [4.0-5.6 mmol/L] - is on or likely to require treatment with corticosteroids - has undergone a surgical procedure within 4 weeks or has planned major surgery during the study - is currently being treated for hyperthyroidism or is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks - has a history of active liver disease (other than non-alcoholic hepatic steatosis) - has had new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or has any of the following disorders within the past 3 months: - acute coronary syndrome - coronary artery intervention - stroke or transient ischemic neurological disorder - has a systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 90 mm Hg - has human immunodeficiency virus (HIV) - has severe peripheral vascular disease - has a clinically important hematological disorder - has a history of malignancy that is less than 5 years from study start, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer - has a positive urine pregnancy test - is pregnant or breast-feeding, or is expecting to conceive or donate eggs during the study - a user of recreational or illicit drugs or has had a recent history of drug abuse
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT01462266
Other Study ID Numbers	0431-260
Has Data Monitoring Committee	No
Information Provided By	Merck Sharp & Dohme Corp.
Study Sponsor	Merck Sharp & Dohme Corp.
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	March 2014