NCT00833027

ALPHA Sitagliptin Add on to Metformin (0431-103)

Completed Phase 4 Results posted Last updated 15 May 2017

What this trial tests

Phase 4 trial testing sitagliptin phosphate in Diabetes Mellitus in 608 participants. Completed in 30 October 2009.

Timeline

1 March 2008

Primary endpoint
30 October 2009

30 October 2009

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	608
Start date	1 March 2008
Primary completion	30 October 2009
Estimated completion	30 October 2009

Drugs / interventions tested

• sitagliptin phosphate — full drug profile →

Conditions studied

• Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with 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 HbA1c at Week 24 Primary · Baseline and Week 24

HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent

Group	Value	95% CI
Sitagliptin 100mg	-0.6	± 0.95

Change From Baseline in HbA1c at Week 12 Secondary · Baseline and Week 12

HbA1c is measured as percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent

Group	Value	95% CI
Sitagliptin 100mg	-0.6	± 0.85

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 100mg

Serious: 17/608 (3%)

Deaths: —

Serious adverse events (19 terms)

Reaction	System	Sitagliptin 100mg
Chest pain	General disorders	—
Depression	Psychiatric disorders	—
Acute coronary syndrome	Cardiac disorders	—
Cardiac failure congestive	Cardiac disorders	—
Cardiac tamponade	Cardiac disorders	—
Myocardial infarction	Cardiac disorders	—
Gastritis	Gastrointestinal disorders	—
Inguinal hernia, obstructive	Gastrointestinal disorders	—
Sudden death	General disorders	—
Gastroenteritis	Infections and infestations	—
Herpes zoster	Infections and infestations	—
Meningoencephalitis herpetic	Infections and infestations	—
Pneumonia	Infections and infestations	—
Accidental overdose	Injury, poisoning and procedural complications	—
Overdose	Injury, poisoning and procedural complications	—
Hypoglycaemia	Metabolism and nutrition disorders	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Chest pain, Depression, Acute coronary syndrome, Cardiac failure congestive, Cardiac tamponade, Myocardial infarction, Gastritis, Inguinal hernia, obstructive.

Data from ClinicalTrials.gov NCT00833027 adverse events section.

Sponsor's own description

Canadian physicians to experience in real life clinical practice the efficacy and tolerability of adding sitagliptin to their patients who have their glycemic levels inadequately controlled while on metformin

Publications & conference data

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