Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin Combined With Metformin in Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02104804
• Date of registration: 02/04/2014
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin Combined With Metformin in Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control
• Scientific title: 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 Chinese Subjects in China With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Insulin Alone or on Insulin in Combination With Metformin
• Date of first enrolment: May 7, 2014
• Target sample size: 953
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02104804
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: Linong Ji, Professor
• Affiliation: People's Hospital of Peking Universty

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Provision of informed consent before participating in the study.

2. Diagnosed with type 2 diabetes.

3. Inadequate glycemic control (screening: HbA1c =7.5% and =11.0% and FPG<270 mg/dL
(15mmol/L). At Day -4 visit, HbA1c =7.5% and =10.5%. and FPG<270 mg/dL (15mmol/L)).

4. On a stable dose of insulin for 8 weeks or longer prior to screening.

5. If taking metformin, subjects should have been taking the same daily dose for 8 weeks
or longer prior to screening.

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

7. Body mass index =45 kg/m^2.

Exclusion Criteria:

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

2. Women who are pregnant or breastfeeding.

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

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

5. Congestive heart failure

6. Chronic or repeated intermittent corticosteroid treatment (subjects receiving stable
doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled).

7. History of unstable or rapidly progressing renal disease.

8. History of alcohol or drug abuse within the previous year.

9. Unstable major psychiatric disorders.

10. History of hemoglobinopathies

11. Immunocompromised status

12. Severe liver disease.

13. In subjects treated with insulin alone a calculated creatinine clearance <50 ml/min.
In patients treated with insulin in combination with metformin a calculated creatinine
clearance <60 ml/min or serum creatinine > 1.5 mg/dL in males or > 1.4mg/dL in
females.

14. Anemia



Age minimum: 18 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Placebo for Saxagliptin

Drug: Saxagliptin 5mg

Primary Outcome(s)

Change in HbA1c From Baseline to Week 24 [Time Frame: Baseline to 24 weeks]

Secondary Outcome(s)

Change in Postprandial Glucose AUC From Baseline to Week 24 During a Meal Tolerance Test [Time Frame: Baseline to 24 weeks]

Percentage of Patients Achieving a Therapeutic Glycaemic Response of HbA1c <7% [Time Frame: At Week 24]

The Analysis of Change in Fasting Plasma Glucose From Baseline to Week 24 (This Was the Average of Weeks 20 and 24) [Time Frame: Baseline to Average of Weeks 20 and 24]

Analysis of Change in 120-minute PPG From Baseline to Week 24 During a Meal Tolerance Test [Time Frame: Baseline to 24 weeks]

Analysis of Change in Mean Total Daily Dose of Insulin From Baseline to Week 24 [Time Frame: Baseline to 24 weeks]

Secondary ID(s)

2014L00001

D1680C00010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/10/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02104804