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Study of Sitagliptin for the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0431-260 AM3)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01462266
First received: October 27, 2011
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  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 Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Sitagliptin
Drug: Comparator: Placebo
Biological: Insulin Glargine
Drug: Metformin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change from baseline in daily insulin dose at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 600
Study Start Date: January 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin
Sitagliptin 100 mg once daily
 Drug: Sitagliptin
Sitagliptin 100 mg tablet once daily for 24 weeks
Other Name: Januvia
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
Placebo Comparator: Placebo
Placebo to sitagliptin once daily
 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01462266     History of Changes
Other Study ID Numbers: 0431-260
Study First Received: October 27, 2011
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Sitagliptin
Insulin
Metformin
 Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013