Trial record 1 of 1 for:
MK-0431E
A Study of the Co-administration of Sitagliptin and Atorvastatin in Inadequately Controlled Type 2 Diabetes Mellitus (MK-0431E-211)
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| ClinicalTrials.gov Identifier: NCT01477853 |
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Recruitment Status :
Terminated
(The study was terminated early by the Sponsor for business reasons.)
First Posted : November 23, 2011
Results First Posted : October 5, 2016
Last Update Posted : July 26, 2018
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
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Brief Summary:
This two-phase study was to 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 to be randomized to one of three treatment arms (sitagliptin monotherapy, atorvastatin monotherapy, or sitagliptin plus atorvastatin) for 16 weeks (Phase A). During Phase B of the study (Weeks 16 through 54), participants were to receive either sitagliptin plus atorvastatin or glimepiride plus atorvastatin. The primary hypotheses were that after 16 weeks of treatment, sitagliptin in combination with atorvastatin reduces A1C from baseline more than atorvastatin alone, and that atorvastatin in combination with sitagliptin lowers LDL-C from baseline more than sitagliptin alone.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 2 Diabetes Mellitus | Drug: Sitagliptin Drug: Atorvastatin Other: Placebo to sitagliptin Other: Placebo to atorvastatin Drug: Metformin (open-label) Drug: Glimepiride (open-label) Drug: Glimepiride (double-blind) Drug: Placebo to glimepiride | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 166 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | October 24, 2011 |
| Actual Primary Completion Date : | December 4, 2012 |
| Actual Study Completion Date : | December 4, 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
| Arm | Intervention/treatment |
|---|---|
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Experimental: Sitagliptin/Sitagliptin + Atorvastatin
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
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Drug: Sitagliptin
Sitagliptin 100 mg tablet orally daily
Other Name: Januvia Drug: Atorvastatin Atorvastatin 80 mg tablet orally daily
Other Name: Lipitor Other: Placebo to atorvastatin Placebo to atorvastatin tablet orally daily. Drug: Metformin (open-label) Participant will remain on prestudy dose of metformin tablets (at least 1500 mg daily) throughout entire study.
Other Name: Glucophage Drug: Glimepiride (open-label) Phase A: Glimepiride 1 or 2 mg tablet 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.
Other Name: Amaryl Drug: Placebo to glimepiride Phase B: placebo to glimepiride tablet orally daily. |
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Active Comparator: Atorvastatin/Atorvastatin + Glimepiride
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
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Drug: Atorvastatin
Atorvastatin 80 mg tablet orally daily
Other Name: Lipitor Other: Placebo to sitagliptin Placebo to sitagliptin tablet orally daily Drug: Metformin (open-label) Participant will remain on prestudy dose of metformin tablets (at least 1500 mg daily) throughout entire study.
Other Name: Glucophage Drug: Glimepiride (double-blind) Phase B: glimepiride up to 6 mg daily for participants not rescued with open-label glimepiride during Phase A. |
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Experimental: Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
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Drug: Sitagliptin
Sitagliptin 100 mg tablet orally daily
Other Name: Januvia Drug: Atorvastatin Atorvastatin 80 mg tablet orally daily
Other Name: Lipitor Drug: Metformin (open-label) Participant will remain on prestudy dose of metformin tablets (at least 1500 mg daily) throughout entire study.
Other Name: Glucophage Drug: Glimepiride (open-label) Phase A: Glimepiride 1 or 2 mg tablet 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.
Other Name: Amaryl Drug: Placebo to glimepiride Phase B: placebo to glimepiride tablet orally daily. |
Primary Outcome Measures :
- Change From Baseline in Hemoglobin A1C (A1C) at Week 16 [ Time Frame: Baseline and Week 16 ]A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent.
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 [ Time Frame: Baseline and Week 16 ]Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
- Number of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to 56 weeks (including 2-week follow-up) ]An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy.
- Number of Participants Who Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 54 weeks ]An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy.
Secondary Outcome Measures :
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16 [ Time Frame: Baseline and Week 16 ]Change from baseline reflects the Week 16 value minus the Week 0 value.
- Percent Change From Baseline in Total Cholesterol at Week 16 [ Time Frame: Baseline and Week 16 ]Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
- Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 [ Time Frame: Baseline and Week 16 ]Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
- Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 [ Time Frame: Baseline and Week 16 ]Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
- Percent Change From Baseline in Triglycerides at Week 16 [ Time Frame: Baseline and Week 16 ]Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
- Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16 [ Time Frame: Baseline and Week 16 ]Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
- Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 16 [ Time Frame: Baseline and Week 16 ]Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 79 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 human immunodeficiency virus (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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477853
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
| Study Director: | Medical Director | Merck Sharp & Dohme LLC |
Study Data/Documents:
CSR Synopsis
| Responsible Party: | Merck Sharp & Dohme LLC |
| ClinicalTrials.gov Identifier: | NCT01477853 |
| Other Study ID Numbers: |
0431E-211 2011-003600-20 ( EudraCT Number ) |
| First Posted: | November 23, 2011 Key Record Dates |
| Results First Posted: | October 5, 2016 |
| Last Update Posted: | July 26, 2018 |
| Last Verified: | July 2018 |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin Sitagliptin Phosphate Glimepiride Atorvastatin Hypoglycemic Agents Physiological Effects of Drugs Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Anti-Arrhythmia Agents Immunosuppressive Agents Immunologic Factors |