Primary outcomeLeast squares mean· Baseline and Week 26
Change From Baseline in Hemoglobin A1c (A1C)
| Group | Value (percent) | Spread |
|---|---|---|
| Sitagliptin +/- Glimepiride | -1.32 | 1.06 |
| Liraglutide | -1.42 | 1.04 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataComparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)
NCTNCT01296412 (opens ClinicalTrials.gov in a new tab)Other id0431-403
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 653 participants (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Design
- Randomized · Open label (no masking)
- Countries
- Not stated
- Start
- 11 Mar 2011
- Primary completion
- 29 Feb 2012
- Completion
- 29 Feb 2012
- First posted
- 15 Feb 2011 (estimated)
- Last update posted
- 9 Jun 2017
- Conditions
- Diabetes Mellitus, Type 2
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201120122013
- Ph 3
Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)
NCT0129641211 Mar 2011 to 29 Feb 2012
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study is being done to compare the effectiveness and safety of two treatment paradigms (oral sitagliptin with or without glimepiride versus liraglutide with or without increased dosing) for the treatment of participants with Type 2 Diabetes that is not adequately controlled with metformin alone. The primary hypothesis postulated that the mean change from baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment is non-inferior to that of participants treated with a liraglutide-based treatment.
Interventions
- sitagliptinDrug
- liraglutideDrug
- glimepirideDrug
- metforminDrug
Arms2
Experimental
Sitagliptin +/- glimepiride
Sitagliptin 100 mg tablet orally once daily for 26 weeks. Participants continued their stable dose of metformin \>=1500 mg orally daily. Participants may have received glimepiride orally for glycemic control.
Active comparator
Liraglutide
Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin \>=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change From Baseline in Hemoglobin A1c (A1C)
Time frame · Baseline and Week 26
Registry description
A1C is measured as percent. Thus, this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent.
Secondary outcomes(3)
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame · Baseline and Week 26
Registry description
Change from baseline at Week 26 is defined as Week 26 minus Week 0.
Percentage of Participants Reaching A1C Goal of <7.0%
Time frame · Week 26
Percentage of Participants Reaching A1C Goal of <6.5%
Time frame · Week 26
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(3)
Secondary outcomeLeast squares mean· Baseline and Week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Sitagliptin +/- Glimepiride | -33.7 | 46.2 |
| Liraglutide | -39.6 | 40.3 |
Secondary outcomeNumber· Week 26
Percentage of Participants Reaching A1C Goal of <7.0%
| Group | Value (percentage of participants) |
|---|---|
| Sitagliptin +/- Glimepiride | 62.8 |
| Liraglutide | 72.3 |
Secondary outcomeNumber· Week 26
Percentage of Participants Reaching A1C Goal of <6.5%
| Group | Value (percentage of participants) |
|---|---|
| Sitagliptin +/- Glimepiride | 33.8 |
| Liraglutide | 38.3 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Sitagliptin +/- GlimepirideSitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin \>=1500 mg orally daily. Participants may have received glimepiride for glycemic control. | – | 17 / 326 | 58 / 326 |
| LiraglutideLiraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin \>=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control. | – | 12 / 324 | 97 / 324 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2013
8 results
Efficacy and safety over 26 weeks of an oral treatment strategy including sitagliptin compared with an injectable treatment strategy with liraglutide in patients with type 2 diabetes mellitus inadequately controlled on metformin: a randomised clinical trial.
Charbonnel et al. 2013Diabetologiacited by 54
PMID 23604551DOI 10.1007/s00125-013-2905-1PUB-23604551
Rights unknown8 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 79 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria
* Type 2 diabetes mellitus.
* On stable dose of metformin monotherapy at a dose of at least 1500 mg per day for at least 12 weeks and a hemoglobin A1C ≥7.0% and ≤11.0%.
* Capable of using a liraglutide pen device.
Exclusion criteria
* History of Type 1 Diabetes mellitus.
* Use of any oral antihyperglycemic agent (AHA) besides metformin, within the prior 12 weeks of screening.
* Cardiovascular disorders within the past 3 months including acute coronary syndrome or new or worsening symptoms of coronary heart disease, coronary artery intervention, stroke, or transient ischemic neurological disorder.
* Impaired liver function.
* Impaired kidney function.
* History of malignancy or clinically important hematological disorder that requires disease-specific treatment (chemotherapy, radiation therapy, surgery) or, in the opinion of the investigator, is likely to recur during the duration of the study.
* History of leukemia, lymphoma, aplastic anemia, myeloproliferative or myelodysplastic diseases, thrombocytopenia, or malignant melanoma, regardless of the time since treatment.
* Pregnancy or breastfeeding, or intention to become pregnant or donate eggs within the projected duration of the study.
* Participation in another study with an investigational drug or device within 12 weeks prior to screening.
* History of hypersensitivity or any contraindication to sitagliptin, liraglutide, glimepiride, or metformin based upon the labels of the country of the investigational site.
* Participation in a weight loss program and not yet in maintenance phase, or starting of a weight loss medication (such as orlistat or phentermine) within the prior 8 weeks.
* Surgery within the prior 4 weeks or major surgery planned during the study.
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
* User of recreational or illicit drugs or recent history (within the last year) of drug abuse or increased alcohol consumption.
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