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Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)
Phase 4 trial testing Sitagliptin/Metformin FDC in Type 2 Diabetes Mellitus in 292 participants. Completed in 29 October 2013.
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 292 |
| Start date | 4 May 2010 |
| Primary completion | 29 October 2013 |
| Estimated completion | 29 October 2013 |
Merck Sharp & Dohme LLC — full company profile →
18 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Change in A1C following 30 weeks of therapy (i.e., A1C at Week 30 minus A1C at baseline).
| Group | Value | 95% CI |
|---|---|---|
| Sitagliptin/Metformin | -1.5 | -1.6 – -1.4 |
| Glimepiride | -0.7 | -0.8 – -0.6 |
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
| Group | Value | 95% CI |
|---|---|---|
| Sitagliptin/Metformin | 88 | |
| Glimepiride | 101 |
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
| Group | Value | 95% CI |
|---|---|---|
| Sitagliptin/Metformin | 8 | |
| Glimepiride | 8 |
Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at baseline).
| Group | Value | 95% CI |
|---|---|---|
| Sitagliptin/Metformin | -47.0 | -51.7 – -42.3 |
| Glimepiride | -23.5 | -28.2 – -18.8 |
Symptomatic episodes assessed as likely to be due to hypoglycemia were reported by investigators as adverse experiences of hypoglycemia. Adverse experiences of hypoglycemia were based on all reports of hypoglycemia; a concurrent glucose measurement was not required.
| Group | Value | 95% CI |
|---|---|---|
| Sitagliptin/Metformin | 5.5 | |
| Glimepiride | 20.1 |
Change in body weight following 30 weeks of therapy (i.e., body weight at Week 30 minus body weight at baseline)
| Group | Value | 95% CI |
|---|---|---|
| Sitagliptin/Metformin | -0.83 | -1.16 – -0.49 |
| Glimepiride | 0.90 | 0.56 – 1.23 |
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%).
| Group | Value | 95% CI |
|---|---|---|
| Sitagliptin/Metformin | 81.2 | |
| Glimepiride | 40.1 |
Time frame: Up to 32 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Sitagliptin/Metformin | Glimepiride |
|---|---|---|---|
| DUODENAL ULCER HAEMORRHAGE | Gastrointestinal disorders | — | — |
| PANCREATITIS ACUTE | Gastrointestinal disorders | — | — |
| ENTEROCOLITIS INFECTIOUS | Infections and infestations | — | — |
| HERPES ZOSTER | Infections and infestations | — | — |
| INFECTIVE SPONDYLITIS | Infections and infestations | — | — |
| INFLUENZA | Infections and infestations | — | — |
| CARTILAGE INJURY | Injury, poisoning and procedural complications | — | — |
| CONTUSION | Injury, poisoning and procedural complications | — | — |
| OVERDOSE | Injury, poisoning and procedural complications | — | — |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | — | — |
| GOUTY ARTHRITIS | Musculoskeletal and connective tissue disorders | — | — |
| SPONDYLOLISTHESIS | Musculoskeletal and connective tissue disorders | — | — |
| PAPILLARY THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| UTERINE LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| INTRACRANIAL ANEURYSM | Nervous system disorders | — | — |
| SYNCOPE | Nervous system disorders | — | — |
| URINARY INCONTINENCE | Renal and urinary disorders | — | — |
| URTICARIA | Skin and subcutaneous tissue disorders | — | — |
| Reaction | System | Sitagliptin/Metformin | Glimepiride |
|---|---|---|---|
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | — | — |
| DYSPEPSIA | Gastrointestinal disorders | — | — |
| NASOPHARYNGITIS | Infections and infestations | — | — |
| DIARRHOEA | Gastrointestinal disorders | — | — |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | — | — |
| NAUSEA | Gastrointestinal disorders | — | — |
Most-reported serious reactions: DUODENAL ULCER HAEMORRHAGE, PANCREATITIS ACUTE, ENTEROCOLITIS INFECTIOUS, HERPES ZOSTER, INFECTIVE SPONDYLITIS, INFLUENZA, CARTILAGE INJURY, CONTUSION.
Data from ClinicalTrials.gov NCT00993187 adverse events section.
This study will assess the effect of sitagliptin/metformin FDC 50/1000 mg (Janumet®), MK-0431A) compared with the effect of glimepiride on hemoglobin A1c (HbA1c). The primary hypothesis is that after 30 weeks, sitagliptin/metformin FDC 50/1000 mg provides superior reduction in HbA1c (mean change from baseline) compared to glimepiride.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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