Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00757588
• Date of registration: 22/09/2008
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin
• Scientific title: A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin
• Date of first enrolment: November 2008
• Target sample size: 455
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00757588
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Brazil, Canada, France, Hungary, India, Mexico, Poland, Russian Federation, South Africa, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

Inclusion Criteria:

- Type 2 diabetes mellitus

- Must have been taking a stable dose of basal or premixed insulin for 8 weeks or longer
prior to screening

- If taking metformin, must have been taking the same daily dose for 8 weeks or longer
prior to screening

- Insulin type should be intermediate- or long-acting (basal) or premixed (premixed
formulation may include short- or rapid-acting insulin as 1 component).

- Inadequate glycemic control (A1C of 7.5% to 11.0%, inclusive)

- Body mass index of 45 kg/m² or lower

- Fasting C-peptide level of 0.8 ng/mL or higher

Exclusion Criteria:

- Symptoms of poorly controlled diabetes, including but not limited to marked polyuria
and polydipsia with greater than 10% weight loss during the last 3 months prior to
screening or other signs and symptoms

- History of diabetic ketoacidosis or hyperosmolar nonketotic coma

- Women of childbearing potential unable or unwilling to use acceptable birth control

- Women who are pregnant or breastfeeding

- Active liver disease

- Anemia

- Chronic or repeated intermittent corticosteroid treatment (participants receiving
stable doses of replacement corticosteroid (except dexamethasone) therapy may be
enrolled)

- Use of short- or rapid-acting insulin

- Significant cardiovascular history defined as: myocardial infarction, coronary
angioplasty or bypass graft, valvular disease or repair, unstable angina pectoris,
transient ischemic attack, or cerebrovascular accident

- Congestive heart failure

- Unstable or rapidly progressing renal disease

- History of alcohol or drug abuse within the previous year

- History of hemoglobinopathies

- Unstable major psychiatric disorders

- Immunocompromised status



Age minimum: 18 Years
Age maximum: 78 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Intervention(s)

Drug: Saxagliptin, 5 mg + insulin

Drug: Placebo + insulin

Primary Outcome(s)

Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF]) [Time Frame: Baseline to Week 24]

Secondary Outcome(s)

Change From Baseline in Fasting Plasma Glucose Values [Time Frame: Baseline to Week 24]

Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF) [Time Frame: Baseline to Week 24]

Change From Baseline in 120-minute PPG Values During an MTT [Time Frame: Baseline to Week 24]

Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT) [Time Frame: Baseline to Week 24]

Percentage of Participants Achieving a Therapeutic Glycemic Response [Time Frame: Baseline to Week 24]

Secondary ID(s)

CV181-057

Eudract-2008-001089-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/12/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00757588