A Multicenter Trial to Evaluate the Efficacy and Safety of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

A Multicenter, Randomized, Double-Blind, Phase 3b 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.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000121

Enrollment

435

Registered

2009-08-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Saxagliptin: Tablets, Oral, 5 mg, once daily, 24 weeks Control Intervention1: Placebo: Tablets, Oral, 0 mg, once daily, 24 weeks ST (+28 LT)

Eligibility

Inclusion criteria

Inclusion criteria: 1. &#8805; 18 and &#8804; 78 years old 2. Type 2 diabetes 3. Taking stable dose of basal or pre-mixed insulin for at least 8 wks 4. If taking metformin, dose must be stable for &#8805; 2 months 5. A1C &#8805; 7.5% and &#8804; 11.0% 6. BMI &#8804; 45 kg/m² 7. Fasting C-peptide &#8805; 0.8 ng/mL

Exclusion criteria

Exclusion criteria: 1. WOCBP unable or unwilling to use acceptable birth control 2. Women who are pregnant or breastfeeding 3. Significant cardiovascular history in last 6 months 4. Active liver disease 5. Renal impairment 6. Anemia 7. Only using short-acting or rapid-acting insulin

Design outcomes

Primary

Measure	Time frame
Change in A1C level from baseline until Wk 24 (or until the last A1C measured before insulin is up-titrated)Timepoint: From baseline until Week 24	—

Secondary

Measure	Time frame
1. The change in the postprandial glucose area under the curve (AUC) in response to a meal tolerance test. 2. The change in 120-minute postprandial plasma glucose (PPG) response to a meal tolerance test. 3. The change in fasting plasma glucose (FPG). 4. The proportion of subjects achieving a therapeutic glycemic response, defined as A1C < 7%. 5. The change in mean total daily insulin dose [ Time Frame: from baseline to Week 24.Timepoint: From baseline until Week 24	—

Measure

Time frame

1. The change in the postprandial glucose area under the curve (AUC) in response to a meal tolerance test. 2. The change in 120-minute postprandial plasma glucose (PPG) response to a meal tolerance test. 3. The change in fasting plasma glucose (FPG). 4. The proportion of subjects achieving a therapeutic glycemic response, defined as A1C < 7%. 5. The change in mean total daily insulin dose [ Time Frame: from baseline to Week 24.Timepoint: From baseline until Week 24

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Countries

India

Contacts

Public ContactDr.Manishkumar Shah

manish.mistry@bms.com022-66288710

Outcome results