NCT00372060

MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)

Completed Phase 3 Results posted Last updated 12 May 2017

What this trial tests

Phase 3 trial testing sitagliptin phosphate in Type 2 Diabetes Mellitus in 134 participants. Completed in 5 February 2008.

Timeline

21 August 2006

Primary endpoint
5 February 2008

5 February 2008

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	134
Start date	21 August 2006
Primary completion	5 February 2008
Estimated completion	5 February 2008

Drugs / interventions tested

• sitagliptin phosphate — full drug profile →
• Comparator: sitagliptin phosphate (MK0431) — full drug profile →
• Comparator: pioglitazone — full drug profile →
• Comparator: placebo (unspecified) — full drug profile →

Conditions studied

• Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

20 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12 Primary · 12 Weeks

Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.

Group	Value	95% CI
Sitagliptin / Sitagliptin	-0.4	-0.6 – -0.3
Placebo / Sitagliptin	0.4	0.3 – 0.5

Change From Baseline in Fasting Plasma Glucose at Week 12 Secondary · 12 Weeks

Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.

Group	Value	95% CI
Sitagliptin / Sitagliptin	-12.2	-17.0 – -7.5
Placebo / Sitagliptin	4.4	-0.3 – 9.1

Change From Baseline in 2 Hour Postprandial Glucose at Week 12 Secondary · 12 weeks

Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.

Group	Value	95% CI
Sitagliptin / Sitagliptin	-42.7	-53.7 – -31.7
Placebo / Sitagliptin	6.4	-4.2 – 17.1

Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 52 Secondary · Week 52 (reflecting change from Week 0) for Sitagliptin/Sitagliptin group; Weeks 52 (reflecting change from Week 12) for Placebo/Sitagliptin group.

Change from the last value before receiving sitagliptin therapy: Week 0 for Sitagliptin/Sitagliptin group and Week 12 for the Placebo/Sitagliptin group.

Group	Value	95% CI
Sitagliptin / Sitagliptin	-0.6	-0.8 – -0.5
Placebo / Sitagliptin	-0.9	-1.1 – -0.7

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sitagliptin/Sitagliptin (Data Through Week 12)

Serious: 3

Deaths: —

Placebo/Sitagliptin (Data Through Week 12)

Serious: 1

Deaths: —

Pooled Sitagliptin (Data Through Week 52)

Serious: 7

Deaths: —

Serious adverse events (10 terms)

Reaction	System	Sitagliptin/Sitagliptin (D…	Placebo/Sitagliptin (Data …	Pooled Sitagliptin (Data T…
Coronary artery stenosis	Cardiac disorders	—	—	—
Enteritis infectious	Infections and infestations	—	—	—
Patella fracture	Injury, poisoning and procedural complications	—	—	—
Pneumothorax traumatic	Injury, poisoning and procedural complications	—	—	—
Rib fracture	Injury, poisoning and procedural complications	—	—	—
Ligament injury	Injury, poisoning and procedural complications	—	—	—
Lower limb fracture	Injury, poisoning and procedural complications	—	—	—
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Cerebral infarction	Nervous system disorders	—	—	—
Hypertension	Vascular disorders	—	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Sitagliptin/Sitagliptin (D…	Placebo/Sitagliptin (Data …	Pooled Sitagliptin (Data T…
Nasopharyngitis	Infections and infestations	—	—	—
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—
Weight increased	Investigations	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—
Periodontitis	Gastrointestinal disorders	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—

Most-reported serious reactions: Coronary artery stenosis, Enteritis infectious, Patella fracture, Pneumothorax traumatic, Rib fracture, Ligament injury, Lower limb fracture, Hepatic neoplasm malignant.

Data from ClinicalTrials.gov NCT00372060 adverse events section.

Sponsor's own description

The clinical study determines the safety and efficacy of MK0431 in patients with type 2 diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Sitagliptin added to treatment with ongoing pioglitazone for up to 52 weeks improves glycemic control in Japanese patients with type 2 diabetes.
   Kashiwagi A, Kadowaki T, Tajima N, Nonaka K, et al · · 2011 · cited 17× · PMID 24843518 · DOI 10.1111/j.2040-1124.2011.00120.x
2. Risk of Fractures Associated with Dipeptidyl Peptidase-4 Inhibitor Treatment: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
   Chen Q, Liu T, Zhou H, Peng H, et al · · 2019 · cited 16× · PMID 31347093 · DOI 10.1007/s13300-019-0668-5