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A Study of the Co-administration of Sitagliptin and Atorvastatin in Inadequately Controlled Type 2 Diabetes Mellitus (MK-0431E-211)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01477853
First received: November 19, 2011
Last updated: November 7, 2014
Last verified: November 2014

November 19, 2011
November 7, 2014
October 2011
December 2012   (final data collection date for primary outcome measure)
  • Change from baseline in hemoglobin A1C (A1C) at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • Percent change from baseline in low density lipoprotein cholesterol (LDL-C) at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01477853 on ClinicalTrials.gov Archive Site
  • Change from baseline in fasting plasma glucose (FPG) at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • Percent change from baseline in total cholesterol at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • Percent change from baseline in apolipoprotein B (Apo B) at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • Percent change from baseline in non-high density lipoprotein cholesterol (non-HDL-C) at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • Percent change from baseline in triglycerides at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • Percent change from baseline in very low-density lipoprotein cholesterol (VLDL-C) at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • Percent change from baseline in high density lipoprotein cholesterol (HDL-C) at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of the Co-administration of Sitagliptin and Atorvastatin in Inadequately Controlled Type 2 Diabetes Mellitus (MK-0431E-211)
A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Co-administration of Sitagliptin and Atorvastatin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy

This 2 phase study will examine if 16 weeks of treatment with sitagliptin in combination with atorvastatin reduces hemoglobin A1C (A1C) and low density lipoprotein cholesterol (LDL-C) from baseline more than atorvastatin alone and sitagliptin alone, respectively. Following a single-blind placebo run-in period, participants were randomized to one of three treatment arms (sitagliptin monotherapy with placebo to atorvastatin, atorvastatin monotherapy with placebo to sitagliptin, or sitagliptin plus atorvastatin) for 16 weeks (Phase A). During Phase B of the study (Weeks 16 through 54), participants received either sitagliptin plus atorvastatin with placebo to glimepiride or glimepiride plus atorvastatin with placebo to sitagliptin.

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 orally daily
    Other Name: Januvia
  • Drug: Atorvastatin
    Atorvastatin 80 mg orally daily
    Other Name: Lipitor
  • Other: Placebo to sitagliptin
    Placebo to sitagliptin orally daily
  • Other: Placebo to atorvastatin
    Placebo to atorvastatin orally daily. Participants not meeting specific goals for low density lipoprotein cholesterol during Phase A will be switched to atorvastatin 80 mg.
  • Drug: Metformin
    Participant will remain on prestudy dose of metformin (at leat 1500 mg daily) throughout entire study.
    Other Name: Glucophage
  • Drug: Glimepiride
    Phase A: Glimepiride 1 or 2 mg once daily with breakfast or the first main meal of the day (titrated up to 6 mg/day) for 16 weeks as rescue therapy for randomized participants not meeting specific glycemic goals. Phase B: glimepiride up to 6 mg daily with placebo to sitagliptin and atorvastatin 80 mg daily
    Other Name: Amaryl
  • Drug: Placebo to glimepiride
    Placebo to glimepiride orally daily
  • Active Comparator: Sitagliptin
    Phase A: sitagliptin 100 mg orally daily plus matching placebo to atorvastatin for 16 weeks
    Interventions:
    • Drug: Sitagliptin
    • Other: Placebo to atorvastatin
    • Drug: Metformin
    • Drug: Glimepiride
  • Active Comparator: Atorvastatin
    Phase A: atorvastatin 80 mg orally daily plus matching placebo to sitagliptin for 16 weeks
    Interventions:
    • Drug: Atorvastatin
    • Other: Placebo to sitagliptin
    • Drug: Metformin
    • Drug: Glimepiride
  • Experimental: Sitagliptin + atorvastatin
    Phase A: sitagliptin 100 mg tablet orally daily plus atorvastatin 80 mg tablet orally daily for 16 weeks
    Interventions:
    • Drug: Sitagliptin
    • Drug: Atorvastatin
    • Drug: Metformin
    • Drug: Glimepiride
  • Active Comparator: Glimepiride + atorvastatin
    Phase B: glimepiride up to 6 mg daily, placebo to sitagliptin, and atorvastatin 80 mg daily for Weeks 16 through 54
    Interventions:
    • Drug: Atorvastatin
    • Other: Placebo to sitagliptin
    • Drug: Metformin
    • Drug: Glimepiride
  • Experimental: Placebo to glimepiride + sitagliptin + atorvastatin
    Phase B: matching placebo to glimepiride plus sitagliptin 100 mg daily and atorvastatin 80 mg daily for Weeks 16 through 54
    Interventions:
    • Drug: Sitagliptin
    • Drug: Atorvastatin
    • Drug: Metformin
    • Drug: Placebo to glimepiride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
166
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • has type 2 diabetes mellitus
  • is a male, or a female who is highly unlikely to conceive
  • is currently on monotherapy with metformin (at least 1500 mg/day) for at least 8 weeks
  • is not on statin therapy or other lipid-lowering agents for at least 6 weeks

Exclusion Criteria:

  • has a history of type 1 diabetes mellitus, ketoacidosis or possibly has type 1 diabetes
  • has ever taken a dipeptidyl peptidase IV inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or a glucagon-like peptide-1 mimetic (such as exenatide or liraglutide), or has required insulin therapy within 12 weeks prior to signing informed consent
  • has been on a peroxisome proliferator-activated receptor gamma agonist within the prior 12 weeks
  • has been treated with a statin or other lipid-lowering agents, including over the counter supplements of fish oils within 6 weeks
  • intends to consume at least 1.2 liters of grapefruit juice per day during the course of the study
  • is on or is likely to require treatment with 14 consecutive days or more, or repeated courses of corticosteroids
  • is on a weight loss program and not in the maintenance phase or has started a weight loss medication (such as orlistat or sibutramine) within the prior 8 weeks
  • has undergone a surgical procedure within the prior 4 weeks
  • has a history of myopathy or rhabdomyolysis with any statin.
  • has cardiovascular disease
  • has New York Heart Association (NYHA) Class III or IV congestive heart failure, inadequately controlled hypertension, a medical history of active liver disease, chronic progressive neuromuscular disorder, is HIV positive, has a clinically significant hematological disorder, uncontrolled endocrine or metabolic disease known to influence glycemic control or serum lipids/lipoproteins, untreated hyperthyroidism or is currently under treatment for hyperthyroidism
  • has a history of malignancy within 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
  • is pregnant or breastfeeding, or is intending to become pregnant or donate eggs within the projected duration of the study and post-study follow-up period
  • uses recreational or illicit drugs or has had a recent history (within the last year) of drug abuse or increased alcohol consumption
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01477853
0431E-211
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
November 2014

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