Clinical trial NCT02273050: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, Dipeptidyl-Peptidase 4 Inhibitors, Saxagliptin, Metformin, Endocrine System Diseases
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-10-23
Enrollment: 1136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change From Baseline in HbA1c From Baseline to Week 24 Provided That it is Prior to Rescue
timeFrame: Baseline to Week 24 (prior to rescue)
Secondary outcomes:
measure: Glycemic Response Defined as HbA1c < 7.0% at Week 24
timeFrame: Week 24 (prior to rescue)
measure: Change From Baseline to Week 24 (Prior to Rescue) in Fasting Plasma Glucose
timeFrame: Baseline to Week 24 prior to rescue
measure: Change From Baseline to Week 24 (Prior to Rescue) in Area Under the Curve From 0-180 Minutes for Postprandial Glucose Response to a Meal Tolerance Test
timeFrame: Baseline to Week 24 prior to rescue
measure: Glycemic Response Defined as HbA1c ≤ 6.5% at Week 24
timeFrame: Week 24 (prior to rescue)
measure: Change From Baseline to Week 24 in 120-minute Postprandial Glucose Response to a Meal Tolerance Test
timeFrame: Baseline to Week 24 prior to rescue
measure: Patients Rescued for Failing to Achieve Pre-specified Glycemic Targets or Discontinuation for Lack of Efficacy During the 24-week Double-blind Treatment Phase
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Changchun
country: China
facility: Research Site
city: Chuangchun
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Guiyang
country: China
facility: Research Site
city: Ha'er bin
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shijiazhuang
country: China
facility: Research Site
city: Siping
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Wuxi
country: China
facility: Research Site
city: Yueyang
country: China
facility: Research Site
Study officials:
affiliation: The General Hospital of People's liberation Army
name: Changyu Pan, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.