NCT00545584

Addition Of Januvia (Sitagliptin) Improves Glycemic Control In Patients Inadequately Controlled By Metformin (MK0431-078)

Completed Phase 3 Results posted Last updated 12 May 2017

What this trial tests

Phase 3 trial testing sitagliptin phosphate in Diabetes Mellitus, Non-Insulin-Dependent in 1,512 participants. Completed in 19 November 2009.

Timeline

1 April 2007

Primary endpoint
19 November 2009

19 November 2009

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,512
Start date	1 April 2007
Primary completion	19 November 2009
Estimated completion	19 November 2009

Drugs / interventions tested

• sitagliptin phosphate — full drug profile →
• Comparator: Diet
• Comparator: Physical Activity

Conditions studied

• Diabetes Mellitus, Non-Insulin-Dependent — all drugs for Diabetes Mellitus, Non-Insulin-Dependent →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Diabetes Mellitus, Non-Insulin-Dependent. 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.

Hemoglobin A1c Measurement Primary · Baseline and Week 24

Hemoglobin A1c (HbA1c) is a measure of glycated hemoglobin in the blood. HbA1c greater than 6.5% was considered inadequately controlled.

Baseline (n=360, 358, and 265, respectively)

Group	Value	95% CI
Sitagliptin With Standard of Care	7.37	± 0.61
Sitagliptin With Diet Advice	7.50	± 0.66
Sitagliptin With Diet and Physical Activity Advice	7.49	± 0.60

Week 24 (n=362, 358, and 265, respectively)

Group	Value	95% CI
Sitagliptin With Standard of Care	7.33	± 1.09
Sitagliptin With Diet Advice	7.42	± 1.15
Sitagliptin With Diet and Physical Activity Advice	7.40	± 1.07

Fasting Plasma Glucose (FPG) Measurement Secondary · Baseline and Week 24

Generally FPG values of \~5.0-7.2 mmol/L would be considered goal (American Diabetes Association).

Baseline (n=350, 350, 252, respectively)

Group	Value	95% CI
Sitagliptin With Standard of Care	8.87	± 1.98
Sitagliptin With Diet Advice	9.00	± 2.03
Sitagliptin With Diet and Physical Activity Advice	8.91	± 1.87

Week 24 (n=310, 303, and 224, respectively)

Group	Value	95% CI
Sitagliptin With Standard of Care	8.21	± 2.07
Sitagliptin With Diet Advice	8.32	± 2.08
Sitagliptin With Diet and Physical Activity Advice	8.47	± 2.17

Adverse events — posted to ClinicalTrials.gov

Time frame: This safety data includes AEs and SAEs that occurred during treatment (Visit 2 to Visit 4).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sitagliptin With Standard of Care

Serious: 8/412 (2%)

Deaths: —

Sitagliptin With Diet Advice

Serious: 18/414 (4%)

Deaths: —

Sitagliptin With Diet and Physical Activity Advice

Serious: 7/305 (2%)

Deaths: —

Serious adverse events (35 terms)

Reaction	System	Sitagliptin With Standard …	Sitagliptin With Diet Advice	Sitagliptin With Diet and …
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
IDIOPATHIC THROMBOCYTOPENIC PURPURA	Blood and lymphatic system disorders	—	—	—
ACUTE CORONARY SYNDROME	Cardiac disorders	—	—	—
ADAMS-STOKES SYNDROME	Cardiac disorders	—	—	—
ANGINA UNSTABLE	Cardiac disorders	—	—	—
MYOCARDIAL INFARCTION	Cardiac disorders	—	—	—
MACULAR OPACITY	Eye disorders	—	—	—
INGUINAL HERNIA	Gastrointestinal disorders	—	—	—
CARDIAC DEATH	General disorders	—	—	—
SUDDEN DEATH	General disorders	—	—	—
CHOLECYSTITIS	Hepatobiliary disorders	—	—	—
ABDOMINAL WALL ABSCESS	Infections and infestations	—	—	—
EAR INFECTION	Infections and infestations	—	—	—
LARYNGITIS	Infections and infestations	—	—	—
PNEUMONIA	Infections and infestations	—	—	—
DRUG EXPOSURE DURING PREGNANCY	Injury, poisoning and procedural complications	—	—	—
FRACTURE	Injury, poisoning and procedural complications	—	—	—
LIMB TRAUMATIC AMPUTATION	Injury, poisoning and procedural complications	—	—	—
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	—	—	—
TENDON RUPTURE	Injury, poisoning and procedural complications	—	—	—
DIABETES MELLITUS	Metabolism and nutrition disorders	—	—	—
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	—	—	—
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
FIBROMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—

Most-reported serious reactions: PROSTATE CANCER, IDIOPATHIC THROMBOCYTOPENIC PURPURA, ACUTE CORONARY SYNDROME, ADAMS-STOKES SYNDROME, ANGINA UNSTABLE, MYOCARDIAL INFARCTION, MACULAR OPACITY, INGUINAL HERNIA.

Data from ClinicalTrials.gov NCT00545584 adverse events section.

Sponsor's own description

To compare the efficacy of three strategies of lifestyle changes associated with Januvia (sitagliptin) 100 mg/day in patients with Type 2 Diabetes Mellitus (T2DM) inadequately controlled by metformin (hemoglobin A1c \[HbA1c\] 6.5-9%). A difference between the three strategies of lifestyle changes was expected.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.