Type 2 Diabetes MellitusPhase 3NCT01477853
A Study of the Co-administration of Sitagliptin and Atorvastatin in Inadequately Controlled Type 2 Diabetes Mellitus (MK-0431E-211)
A Phase 3 study testing Sitagliptin, Atorvastatin and Metformin (open-label) in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Sitagliptin, Atorvastatin and Metformin (open-label)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- 24 Oct 2011to 4 Dec 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
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
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Sitagliptin, Atorvastatin, Placebo to sitagliptin, Placebo to atorvastatin, Metformin (open-label)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Januvia
Sitagliptin 100 mg tablet orally daily
AtorvastatinDrug
Also called Lipitor
Atorvastatin 80 mg tablet orally daily
Placebo to sitagliptinOther
Placebo to sitagliptin tablet orally daily
Placebo to atorvastatinOther
Placebo to atorvastatin tablet orally daily.
Metformin (open-label)Drug
Also called Glucophage
Participant will remain on prestudy dose of metformin tablets (at least 1500 mg daily) throughout entire study.
Glimepiride (open-label)Drug
Also called Amaryl
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.
Glimepiride (double-blind)Drug
Phase B: glimepiride up to 6 mg daily for participants not rescued with open-label glimepiride during Phase A.
Placebo to glimepirideDrug
Phase B: placebo to glimepiride tablet orally daily.
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin/Sitagliptin + Atorvastatin | Experimental | 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. Receives: Drug: Sitagliptin; Drug: Atorvastatin; Other: Placebo to atorvastatin; Drug: Metformin (open-label); Drug: Glimepiride (open-label); Drug: Placebo to glimepiride |
| Atorvastatin/Atorvastatin + Glimepiride | Active comparator | 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. Receives: Drug: Atorvastatin; Other: Placebo to sitagliptin; Drug: Metformin (open-label); Drug: Glimepiride (double-blind) |
| Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin | Experimental | 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. Receives: Drug: Sitagliptin; Drug: Atorvastatin; Drug: Metformin (open-label); Drug: Glimepiride (open-label); Drug: Placebo to glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin A1C (A1C) at Week 16
A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent.
Measured: Baseline and Week 16
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at 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%.
Measured: Baseline and Week 16
Number of Participants Who Experienced at Least One Adverse Event
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.
Measured: Up to 56 weeks (including 2-week follow-up)
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
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.
Measured: Up to 54 weeks
Secondary outcomes (7)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16
Change from baseline reflects the Week 16 value minus the Week 0 value.
Measured: Baseline and Week 16
Percent Change From Baseline in Total Cholesterol at 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%.
Measured: Baseline and Week 16
Percent Change From Baseline in Apolipoprotein B (Apo B) at 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%.
Measured: Baseline and Week 16
Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at 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%.
Measured: Baseline and Week 16
Percent Change From Baseline in Triglycerides at 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%.
Measured: Baseline and Week 16
Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at 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%.
Measured: Baseline and Week 16
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at 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%.
Measured: Baseline and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study start24 Oct 2011
- Primary completion4 Dec 2012
- Study completion4 Dec 2012
Why it stopped: The study was terminated early by the Sponsor for business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477853
- Sponsor's protocol ID
- 0431E-211
- Other IDs
- 2011-003600-20
- Status last verified
- Jul 2018
- First submitted
- 19 Nov 2011
- Last updated
- 26 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01477853
- Acronym / sponsor ID
- 0431E-211
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early by the Sponsor for business reasons.
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2011 (actual)
- Primary completion
- 4 Dec 2012 (actual)
- Study completion
- 4 Dec 2012 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Posted 5 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin/Sitagliptin + Atorvastatin | Experimental | Drug: Sitagliptin, Drug: Atorvastatin, Other: Placebo to atorvastatin, Drug: Metformin (open-label), Drug: Glimepiride (open-label), Drug: Placebo to glimepirideIn 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. |
| Atorvastatin/Atorvastatin + Glimepiride | Active comparator | Drug: Atorvastatin, Other: Placebo to sitagliptin, Drug: Metformin (open-label), Drug: Glimepiride (double-blind)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. |
| Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin | Experimental | Drug: Sitagliptin, Drug: Atorvastatin, Drug: Metformin (open-label), Drug: Glimepiride (open-label), Drug: Placebo to glimepirideIn 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SitagliptinAlso: JanuviaSitagliptin 100 mg tablet orally daily | Drug | Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin, Sitagliptin/Sitagliptin + Atorvastatin |
| AtorvastatinAlso: LipitorAtorvastatin 80 mg tablet orally daily | Drug | Atorvastatin/Atorvastatin + Glimepiride, Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin, Sitagliptin/Sitagliptin + Atorvastatin |
| Placebo to sitagliptinPlacebo to sitagliptin tablet orally daily | Other | Atorvastatin/Atorvastatin + Glimepiride |
| Placebo to atorvastatinPlacebo to atorvastatin tablet orally daily. | Other | Sitagliptin/Sitagliptin + Atorvastatin |
| Metformin (open-label)Also: GlucophageParticipant will remain on prestudy dose of metformin tablets (at least 1500 mg daily) throughout entire study. | Drug | Atorvastatin/Atorvastatin + Glimepiride, Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin, Sitagliptin/Sitagliptin + Atorvastatin |
| Glimepiride (open-label)Also: AmarylPhase 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. | Drug | Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin, Sitagliptin/Sitagliptin + Atorvastatin |
| Glimepiride (double-blind)Phase B: glimepiride up to 6 mg daily for participants not rescued with open-label glimepiride during Phase A. | Drug | Atorvastatin/Atorvastatin + Glimepiride |
| Placebo to glimepiridePhase B: placebo to glimepiride tablet orally daily. | Drug | Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin, Sitagliptin/Sitagliptin + Atorvastatin |
Primary outcome
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.
7 secondary outcomes
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16
Time frame: Baseline and Week 16
Percent Change From Baseline in Total Cholesterol at Week 16
Time frame: Baseline and Week 16
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16
Time frame: Baseline and Week 16
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 in Triglycerides at Week 16
Time frame: Baseline and Week 16
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 in High Density Lipoprotein Cholesterol (HDL-C) at Week 16
Time frame: Baseline and Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sitagliptin, Atorvastatin and Metformin (open-label) in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (time frame: Baseline and Week 16). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.