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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01462266
First received: October 27, 2011
Last updated: March 7, 2014
Last verified: March 2014

October 27, 2011
March 7, 2014
January 2012
June 2013   (final data collection date for primary outcome measure)
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)
Change from baseline in daily insulin dose at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01462266 on ClinicalTrials.gov Archive Site
  • 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.
  • Change from baseline in hemoglobin A1c (A1C) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Percent of participants achieving fasting glucose target [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Fasting glucose target was defined as 72-100 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 ]
    First time to achieve the fasting glucose target. Fasting glucose target was defined as 72-100 mg/dL (4.0-5.6 mmol/L).
Not Provided
Not Provided
 
Study of Sitagliptin for the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0431-260)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Sitagliptin
    Sitagliptin 100 mg tablet once daily for 24 weeks
    Other Name: Januvia
  • Drug: 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 Name: Glucophage
  • Experimental: Sitagliptin
    Sitagliptin 100 mg once daily
    Interventions:
    • Drug: Sitagliptin
    • Biological: Insulin Glargine
    • Drug: Metformin
  • Placebo Comparator: Placebo
    Placebo to sitagliptin once daily
    Interventions:
    • Drug: Comparator: Placebo
    • Biological: Insulin Glargine
    • Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
660
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01462266
0431-260
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2014

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