A Phase 3 interventional study of Sitagliptin phosphate and Comparator: Placebo in Type 2 Diabetes Mellitus, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-16.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
This study will evaluate whether the addition of sitagliptin reduces hemoglobin A1C (A1C) more than the addition of placebo for participants with type 2 diabetes mellitus (T2DM) on a steady dose of acarbose. The primary hypothesis is that the addition of sitagliptin 100 mg once daily (q.d.) reduces A1C more than the addition of placebo in participants with T2DM with inadequate glycemic control on acarbose monotherapy.
The study includes an 8-week antihyperglycemic agent (AHA) wash-off period* (which includes a 2-week single-blind placebo run-in period) followed by a 24-week double-blind treatment period. All participants will receive open-label acarbose at a minimum dose of 50 mg three times daily (t.i.d.) during the run-in and treatment periods.
*: Wash-off only applicable to patients who were on acarbose and another AHA.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 380 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
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Exclusion Criteria:
Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily \[t.i.d.\])
Drug: Sitagliptin phosphate · Drug: Acarbose · Drug: Glimepiride
Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
Drug: Comparator: Placebo · Drug: Acarbose · Drug: Glimepiride
Sitagliptin, 100 mg tablet once daily, orally for 24 weeks
Also known as: Januvia
Placebo, to match sitagliptin tablet, once daily, orally for 24 weeks
Acarbose 50 mg or 100 mg tablet, 3 times daily, orally (continuing on the stable dose established prior to screening) for 24 weeks
Also known as: Precose
Participants not meeting specific glycemic goals during the study will use glimepiride as rescue therapy. For countries where glimepiride is not available, participants will receive a sulfonylurea marketed in that country as rescue therapy.
Also known as: Amaryl®, Glimy
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. Efficacy analyses treated data as missing after the initiation of rescue therapy.
Time frame: Baseline and Week 24
Number of Participants Who Experienced at Least One Adverse Event
Time frame: Up to Week 24 + 14 Day Post-Study Follow-up
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 24 Weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Efficacy analyses treated data as missing after the initiation of rescue therapy.
Time frame: Baseline and Week 24
| Milestone | Sitagliptin | Placebo |
|---|---|---|
| Started | 191 | 190 |
| Completed | 177 | 164 |
| Not completed | 14 | 26 |
| Withdrew: Adverse event | 6 | 4 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: Lost to follow-up | 3 | 4 |
| Withdrew: Physician decision | 0 | 3 |
| Withdrew: Protocol violation | 0 | 2 |
| Withdrew: Withdrawal by subject | 5 | 12 |
A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. Efficacy analyses treated data as missing after the initiation of rescue therapy.
| Percent | Sitagliptin | Placebo |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (A1C) at Week 24 | -0.76 (-0.93 to -0.59) | -0.14 (-0.32 to 0.03) |
Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Efficacy analyses treated data as missing after the initiation of rescue therapy.
| mg/dL | Sitagliptin | Placebo |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | -17.9 (-25.3 to -10.5) | -3.5 (-11.1 to 4.1) |
| Participants | Sitagliptin | Placebo |
|---|---|---|
| Number of Participants Who Experienced at Least One Adverse Event | 62 | 58 |
| Participants | Sitagliptin | Placebo |
|---|---|---|
| Number of Participants Who Discontinued Study Drug Due to an Adverse Event | 5 | 2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sitagliptin | — | 10/191 (5.2%) | 0/191 (0%) |
| Placebo | — | 1/189 (0.5%) | 0/189 (0%) |
| Event | Sitagliptin | Placebo |
|---|---|---|
| CholecystitisHepatobiliary disorders | 2/191 | 0/189 |
| Invasive ductal breast carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/191 | 1/189 |
| Cardia flutterCardiac disorders | 1/191 | 0/189 |
| Pancreatitis chronicGastrointestinal disorders | 1/191 | 0/189 |
| Bile duct stoneHepatobiliary disorders | 1/191 | 0/189 |
| GastroenteritisInfections and infestations | 1/191 | 0/189 |
| ThymomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/191 | 0/189 |
| Cerebral infarctionNervous system disorders | 1/191 | 0/189 |
| Transient ischaemic attackNervous system disorders | 1/191 | 0/189 |
| Calculus urinaryRenal and urinary disorders | 1/191 | 0/189 |
All participants randomized population. The baseline characteristics module does not include the second sequential randomization of a participant in the placebo group. Data for the second sequential randomization were excluded from the efficacy and safety analyses.
| Age, Continuous(Years) | Sitagliptin | Placebo | Total |
|---|---|---|---|
| Mean | 56.5 ± 8.9 | 57.8 ± 9.5 | 57.1 ± 9.2 |
| Sex: Female, Male(Participants) | Sitagliptin | Placebo | Total |
|---|---|---|---|
| Female | 94 | 92 | 186 |
| Male | 97 | 97 | 194 |
| Hemoglobin A1c (A1C)(Percent) | Sitagliptin | Placebo | Total |
|---|---|---|---|
| Mean | 8.09 ± 0.79 | 8.08 ± 0.90 | 8.08 ± 0.85 |
| Fasting plasma glucose(mg/dL) | Sitagliptin | Placebo | Total |
|---|---|---|---|
| Mean | 177.3 ± 37.5 | 177.5 ± 40.2 | 177.4 ± 38.8 |
No study locations are listed for this record.
Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC