Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control

A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise.

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients with inadequate glycaemic control with diet and exercise.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Placebo; Drug: Saxagliptin

• Study Type: Interventional
• Enrollment (Actual): 568
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Research Site
  • Chongqing, China
    • Research Site
  • Tianjin, China
    • Research Site
  • Anhui
    • Hefei, Anhui, China
      • Research Site
  • Fujian
    • Fuzhou, Fujian, China
      • Research Site
  • Guangdong
    • Guangzhou, Guangdong, China
      • Research Site
  • Hebei
    • Shijiazhuang, Hebei, China
      • Research Site
  • Hunan
    • Changsha, Hunan, China
      • Research Site
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Research Site
  • Jilin
    • Changchun, Jilin, China
      • Research Site
  • Liaoning
    • Dalian, Liaoning, China
      • Research Site
    • Shenyang, Liaoning, China
      • Research Site
  • Shanghai
    • Shanghai, Shanghai, China
      • Research Site
  • Sichuan
    • Chengdu, Sichuan, China
      • Research Site
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Research Site
• India
  • Coimbatore, India
    • Research Site
  • Andhra Pradesh
    • Hyderabaad, Andhra Pradesh, India
      • Research Site
  • Karnataka
    • Bangalore, Karnataka, India
      • Research Site
    • Mangalore, Karnataka, India
      • Research Site
  • Maharashtra
    • Mumbai, Maharashtra, India
      • Research Site
    • Nagpur, Maharashtra, India
      • Research Site
    • Pune, Maharashtra, India
      • Research Site
• Korea, Republic of
  • Daegu, Korea, Republic of
    • Research Site
  • Seoul, Korea, Republic of
    • Research Site
  • Chonbuk
    • Jeonju, Chonbuk, Korea, Republic of
      • Research Site
• Philippines
  • Cebu City, Philippines
    • Research Site
  • Makati City, Philippines
    • Research Site
  • Manila, Philippines
    • Research Site
  • Marikina City, Philippines
    • Research Site
  • Quezon City, Philippines
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with Type 2 diabetes
• Patients should be drug naïve ie, not received medical treatment for diabetes,
• HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)

Exclusion Criteria:

• Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes),
• Type 1 diabetes,history of ketoacidosis or hyperosmolar non-ketonic koma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; oral tablet, once daily for 24 weeks
Experimental: Saxagliptin 5mg	Drug: Saxagliptin; 5mg, oral tablet, once daily for 24 weeks; Other Names: Onglyza

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)	Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.	Baseline , Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)	Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (Last Observation Carried Forward (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.	Baseline, Week 24
Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)	Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.	Baseline, Week 24
Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants	Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication	Baseline , Week 24
Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants	Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication	Baseline , Week 24
Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24	Proportion of participants (expressed in percentage of total participants) achieving HbA1c < 7.0% for saxagliptin versus placebo at week 24. HbA1c Data were excluded on and after rescue medication	Baseline, Week 24

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Bristol-Myers Squibb
• Investigators: Study Director: Peter Öhman, MD, PhD, AstraZeneca, Wilmington, USA; Study Chair: Deborah Price, MSc, AstraZeneca, Wilmington, USA

Publications and helpful links

General Publications

• Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: June 16, 2008
• First Submitted That Met QC Criteria: June 16, 2008
• First Posted (Estimate): June 17, 2008

Study Record Updates

• Last Update Posted (Estimate): September 21, 2011
• Last Update Submitted That Met QC Criteria: August 17, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: DPP-4 inhibitors; Incretins; HBA1c
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Saxagliptin
• Other Study ID Numbers: D1680C00005