A Phase 3 interventional study of Comparator: sitagliptin phosphate (sitagliptin) and sitagliptin phosphate (+) metformin hydrochloride in Type 2 Diabetes Mellitus, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 78 Years. Per ClinicalTrials.gov, last updated 2017-05-12.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of sitagliptin and MK0431A in comparison to a commonly used medication in patients with type 2 diabetes.
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This study's enrollment of 492 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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In Phase A (Treatment Day 1 to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to 15 mg pioglitazone q.d. for 6 weeks followed by matching placebo to 30 mg pioglitazone for the next 6 weeks. In Phase B (Treatment Week 12-Week 40), participants were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks; as well as matching placebo to 45 mg pioglitazone.
Drug: Comparator: sitagliptin phosphate (sitagliptin) · Drug: sitagliptin phosphate (+) metformin hydrochloride · Drug: Matching placebo to pioglitazone
In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone and matching placebo to sitagliptin. At Week 6, participants were up-titrated to 30 mg pioglitazone q.d. In Phase B (Treatment Week 12 to Week 40), participants were administered 45 mg pioglitazone q.d.; as well as matching placebo to Sita/Met FDC (50/500 increased to 50/1000 b.i.d. after 4 weeks).
Drug: Comparator: pioglitazone · Drug: Matching placebo to sitagliptin · Drug: Matching Placebo to Sita/Met FDC
sitagliptin 100 mg tablet q.d. orally for a 12-wk treatment period
Also known as: MK0431, Januvia™
sitagliptin/metformin HCl (Sita/Met) 50/500 mg b.i.d. orally and then 50/1000 mg b.i.d. orally for a 28-wk treatment period
Also known as: MK-0431A, Janumet™
pioglitazone 15 mg tablet q.d. orally for 6 weeks, followed by 30 mg q.d orally for 6 weeks, followed by 45 mg q.d. orally, up to 40 weeks.
Also known as: Actos®
matching placebo to pioglitazone tablet q.d. orally, for a 40-wk treatment period. Participants were administered matching placebo the 15 mg pioglitazone q.d. orally for 6 weeks, followed by matching placebo to 30 mg pioglitazone q.d orally for 6 weeks, followed by matching placebo to 45 mg pioglitazone q.d. orally, up to 40 weeks.
matching placebo to sitagliptin q.d., orally for a 12-wk treatment period.
matching placebo to Sita/Met FDC - 50/500 mg b.i.d. for 4 weeks and then 50/1000 mg b.i.d. orally for a 28-wk treatment period (Week 12 to Week 40).
Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks
The change in A1C, compared to baseline for the Sita/Met FDC and the pioglitazone groups at Week 40. A1C represents percentage of glycosylated hemoglobin.
Time frame: Baseline to 40 weeks
Change in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks
The change in A1C compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. A1c represents percentage of glycosylated hemoglobin.
Time frame: Baseline to 12 weeks
Change in 2-hour Postprandial Glucose (PMG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks
The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the Sita/Met FDC and the pioglitazone groups at Week 40.
Time frame: Baseline and 40 weeks
Change in 2-hour Postprandial Glucose (PMG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks
The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the participants treated with Sitagliptin or Pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.
Time frame: Baseline to 12 weeks
Change in Fasting Plasma Glucose (FPG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks
The change in FPG compared to baseline was measured for the Sita/Met FDC and the pioglitazone groups at Week 40.
Time frame: Baseline and 40 weeks
Change in Fasting Plasma Glucose (FPG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks
The change in FPG compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.
Time frame: Baseline to 12 weeks
| Milestone | Sita/Met FDC | Pioglitazone |
|---|---|---|
| Started | 244 | 248 |
| Completed | 224 | 231 |
| Not completed | 20 | 17 |
| Withdrew: Adverse event | 3 | 0 |
| Withdrew: Creatinine/crcl -increase in creatinine | 0 | 2 |
| Withdrew: Hyperglycemia | 0 | 1 |
| Withdrew: Lost to follow-up | 6 | 4 |
| Withdrew: Physician decision | 2 | 0 |
| Withdrew: Protocol violation | 2 | 3 |
| Withdrew: Withdrawal by subject | 7 | 7 |
| Milestone | Sita/Met FDC | Pioglitazone |
|---|---|---|
| Started | 224 | 231 |
| Completed | 187 | 200 |
| Not completed | 37 | 31 |
| Withdrew: Adverse event | 6 | 6 |
| Withdrew: Hyperglycemia | 10 | 9 |
| Withdrew: Lost to follow-up | 6 | 4 |
| Withdrew: Physician decision | 4 | 2 |
| Withdrew: Pregnancy | 0 | 1 |
| Withdrew: Protocol violation | 3 | 3 |
| Withdrew: Withdrawal by subject | 8 | 6 |
The change in A1C, compared to baseline for the Sita/Met FDC and the pioglitazone groups at Week 40. A1C represents percentage of glycosylated hemoglobin.
| percentage of glycosylated hemoglobin | Sita/Met FDC | Pioglitazone |
|---|---|---|
| Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks | -1.75 (-1.92 to -1.59) | -1.38 (-1.55 to -1.21) |
The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the Sita/Met FDC and the pioglitazone groups at Week 40.
| mg/dL | Sita/Met FDC | Pioglitazone |
|---|---|---|
| Change in 2-hour Postprandial Glucose (PMG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks | -90.3 (-99.6 to -81.0) | -69.1 (-78.2 to -60.0) |
The change in A1C compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. A1c represents percentage of glycosylated hemoglobin.
| percentage of glycosylated hemoglobin | Sitagliptin (Phase A) | Pioglitazone (Phase A) |
|---|---|---|
| Change in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks | -1.03 (-1.18 to -0.88) | -0.87 (-1.02 to -0.72) |
The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the participants treated with Sitagliptin or Pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.
| mg/dL | Sitagliptin (Phase A) | Pioglitazone (Phase A) |
|---|---|---|
| Change in 2-hour Postprandial Glucose (PMG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks | -52.8 (-62.4 to -43.3) | -50.1 (-59.4 to -40.7) |
The change in FPG compared to baseline was measured for the Sita/Met FDC and the pioglitazone groups at Week 40.
| mg/dL | Sita/Met FDC | Pioglitazone |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks | -45.8 (-51.1 to -40.5) | -37.6 (-42.8 to -32.4) |
The change in FPG compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.
| mg/dL | Sitagliptin (Phase A) | Pioglitazone (Phase A) |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks | -26.6 (-31.7 to -21.5) | -28.0 (-33.0 to -23.0) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sitagliptin (Weeks 0-12) | — | 3/244 (1.2%) | 7/244 (2.9%) |
| Pioglitazone (Weeks 0-12) | — | 1/248 (0.4%) | 15/248 (6%) |
| Sita/Met FDC (Weeks 0-40) | — | 8/222 (3.6%) | 20/222 (9%) |
| Pioglitazone (Weeks 0-40) | — | 3/230 (1.3%) | 33/230 (14.3%) |
| Event | Sitagliptin (Weeks 0-12) | Pioglitazone (Weeks 0-12) | Sita/Met FDC (Weeks 0-40) | Pioglitazone (Weeks 0-40) |
|---|---|---|---|---|
| Angina pectorisCardiac disorders | 0/244 | 0/248 | 1/222 | 0/230 |
| Myocardial infarctionCardiac disorders | 0/244 | 0/248 | 1/222 | 0/230 |
| Inguinal herniaGastrointestinal disorders | 0/244 | 0/248 | 1/222 | 0/230 |
| Sudden cardiac deathGeneral disorders | 0/244 | 0/248 | 1/222 | 0/230 |
| GastroenteritisInfections and infestations | 1/244 | 0/248 | 1/222 | 0/230 |
| Eye injuryInjury, poisoning and procedural complications | 0/244 | 0/248 | 1/222 | 0/230 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 0/244 | 0/248 | 1/222 | 0/230 |
| SyncopeNervous system disorders | 0/244 | 0/248 | 1/222 | 0/230 |
| ProstatitisReproductive system and breast disorders | 0/244 | 0/248 | 1/222 | 0/230 |
| Atrial fibrillationCardiac disorders | 0/244 | 0/248 | 0/222 | 1/230 |
| Event | Sitagliptin (Weeks 0-12) | Pioglitazone (Weeks 0-12) | Sita/Met FDC (Weeks 0-40) | Pioglitazone (Weeks 0-40) |
|---|---|---|---|---|
| Oedema peripheralGeneral disorders | 0/244 | 7/248 | 2/222 | 13/230 |
| NasopharyngitisInfections and infestations | 4/244 | 6/248 | 12/222 | 12/230 |
| HeadacheNervous system disorders | 4/244 | 4/248 | 9/222 | 12/230 |
| Age, Continuous(years) | Sita/Met FDC | Pioglitazone | Total |
|---|---|---|---|
| Mean | 50.5 ± 10.9 | 51.7 ± 10.1 | 51.1 ± 10.5 |
| Sex: Female, Male(Participants) | Sita/Met FDC | Pioglitazone | Total |
|---|---|---|---|
| Female | 92 | 100 | 192 |
| Male | 152 | 148 | 300 |
No study locations are listed for this record.
Plan to share: Yes — http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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