Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Drug Naive Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control

NCT ID: NCT02273050

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-08-31

Brief Summary

A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control

Detailed Description

Allocation: Randomized Endpoint Classification: Efficacy/Safety study Intervention Model: Parallel Assignment Masking: Double Blind Primary Purpose: Treatment

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Saxagliptin 5 mg + Metformin (500 mg with titration)

Saxagliptin 5 mg once daily and metformin 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed.

Group Type: EXPERIMENTAL

Saxagliptin 5 mg

Intervention Type: DRUG

Tablet, Oral, 5 mg, Once daily in the morning

Metformin 500 mg with titration

Intervention Type: DRUG

Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.

Saxagliptin 5 mg + Placebo

Saxagliptin 5 mg once daily and Placebo 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed.

Group Type: ACTIVE_COMPARATOR

Saxagliptin 5 mg

Intervention Type: DRUG

Tablet, Oral, 5 mg, Once daily in the morning

Placebo 500 mg for metformin (with titration)

Intervention Type: DRUG

Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.

Metformin (500 mg with titration) + Placebo

Placebo 5 mg once daily and metformin 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed.

Group Type: ACTIVE_COMPARATOR

Placebo 5 mg for Saxagliptin

Intervention Type: DRUG

Tablet, Oral, 5 mg, Once daily in the morning

Metformin 500 mg with titration

Intervention Type: DRUG

Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.

Interventions

Saxagliptin 5 mg

Tablet, Oral, 5 mg, Once daily in the morning

Intervention Type: DRUG

Placebo 5 mg for Saxagliptin

Tablet, Oral, 5 mg, Once daily in the morning

Intervention Type: DRUG

Placebo 500 mg for metformin (with titration)

Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.

Intervention Type: DRUG

Metformin 500 mg with titration

Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.

Intervention Type: DRUG

Other Intervention Names

Onglyza; BMS-477118; Glucophage

Eligibility Criteria

Inclusion Criteria

1. Subjects with type 2 diabetes mellitus; 2. HbA1c ≥8% but ≤12%; 3.Fasting C-peptide ≥1.0 ng/ml; 4. Subject will be drug naïve; 5. Body mass index ≤40 kg/m2.

Exclusion Criteria

1. Symptoms of poorly controlled diabetes; 2. Chronic or repeated intermittent corticosteroid treatment ; 3. Calculated creatinine clearance <60 ml/min or serum creatinine >132.6 μmol/L (>1.5 mg/dL) for men, >123.8 μmol/L (>1.4 mg/dL) for women; 4. Creatine Kinase ≥3x ULN; 5.Abnormal TSH value at screening will be further evaluated by free T4, subjects with an abnormal free T4 will be excluded; 6. History of administration of any antihyperglycaemic therapy for a total of 28 days or for more than three consecutive days or a total of seven non-consecutive days during the eight weeks prior to screening; 7. Current treatment with a strong CYP3A4/5 inhibitor; 8. Prior treatment with saxagliptin or any DPP-4 inhibitor; 9. Significant or history of cardiovascular disease, renal disease, psychiatric disorders, Immunocompromised individuals, hemoglobinopathies, liver disease, Pancreatitis.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Changyu Pan, Professor

Role: PRINCIPAL_INVESTIGATOR

The General Hospital of People's liberation Army

Locations

Research Site

Beijing, , China

Research Site

Changchun, , China

Research Site

Chuangchun, , China

Research Site

Fuzhou, , China

Research Site

Guiyang, , China

Research Site

Hangzhou, , China

Research Site

Ha’erbin, , China

Research Site

Hefei, , China

Research Site

Jinan, , China

Research Site

Nanchang, , China

Research Site

Nanjing, , China

Research Site

Shanghai, , China

Research Site

Shijiazhuang, , China

Research Site

Siping, , China

Research Site

Tianjin, , China

Research Site

Wuxi, , China

Research Site

Yueyang, , China

Countries

China

References

Dou J, Ma J, Liu J, Wang C, Johnsson E, Yao H, Zhao J, Pan C. Efficacy and safety of saxagliptin in combination with metformin as initial therapy in Chinese patients with type 2 diabetes: Results from the START study, a multicentre, randomized, double-blind, active-controlled, phase 3 trial. Diabetes Obes Metab. 2018 Mar;20(3):590-598. doi: 10.1111/dom.13117. Epub 2017 Oct 26.

Reference Type: DERIVED

PMID: 28926170 (View on PubMed)

Other Identifiers

D1680C00009

Identifier Type: -

Identifier Source: org_study_id