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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

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ClinicalTrials.gov Identifier: NCT02273050
Recruitment Status : Completed
First Posted : October 23, 2014
Results First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Saxagliptin 5 mg Drug: Placebo 5 mg for Saxagliptin Drug: Placebo 500 mg for metformin (with titration) Drug: Metformin 500 mg with titration Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Saxagliptin 5 mg
Tablet, Oral, 5 mg, Once daily in the morning
Other Names:
  • Onglyza
  • BMS-477118

Drug: Metformin 500 mg with titration
Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.
Other Name: Glucophage

Active Comparator: 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.
Drug: Saxagliptin 5 mg
Tablet, Oral, 5 mg, Once daily in the morning
Other Names:
  • Onglyza
  • BMS-477118

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.

Active Comparator: 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.
Drug: Placebo 5 mg for Saxagliptin
Tablet, Oral, 5 mg, Once daily in the morning

Drug: Metformin 500 mg with titration
Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.
Other Name: Glucophage




Primary Outcome Measures :
  1. Change From Baseline in HbA1c From Baseline to Week 24 Provided That it is Prior to Rescue [ Time Frame: Baseline to Week 24 (prior to rescue) ]
    To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to reduction in HbA1c (%) at the end of 24 weeks of double-blinded treatment.


Secondary Outcome Measures :
  1. Glycemic Response Defined as HbA1c < 7.0% at Week 24 [ Time Frame: Week 24 (prior to rescue) ]
    To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects achieving a therapeutic glycemic response defined as HbA1c < 7.0% at the end of 24 weeks of double-blinded treatment.

  2. Change From Baseline to Week 24 (Prior to Rescue) in Fasting Plasma Glucose [ Time Frame: Baseline to Week 24 prior to rescue ]
    To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to reduction in fasting plasma glucose at the end of 24 weeks of double-blinded treatment.

  3. 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 [ Time Frame: Baseline to Week 24 prior to rescue ]
    To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to change in 180-minute postprandial glucose response to a meal tolerance test at the end of 24 weeks of double-blinded treatment.

  4. Glycemic Response Defined as HbA1c ≤ 6.5% at Week 24 [ Time Frame: Week 24 (prior to rescue) ]
    To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects achieving a therapeutic glycemic response defined as HbA1c ≤ 6.5% at the end of 24 weeks of double-blinded treatment.

  5. Change From Baseline to Week 24 in 120-minute Postprandial Glucose Response to a Meal Tolerance Test [ Time Frame: Baseline to Week 24 prior to rescue ]
    To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to change in 120-minute postprandial glucose response to a meal tolerance test at the end of 24 weeks of double-blinded treatment.

  6. Patients Rescued for Failing to Achieve Pre-specified Glycemic Targets or Discontinuation for Lack of Efficacy During the 24-week Double-blind Treatment Phase [ Time Frame: Baseline to Week 24 ]
    To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24 weeks of double-blinded treatment.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273050


Locations
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China
Research Site
Beijing, China
Research Site
Changchun, China
Research Site
Chuangchun, China
Research Site
Fuzhou, China
Research Site
Guiyang, China
Research Site
Ha'er bin, China
Research Site
Hangzhou, 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
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Changyu Pan, Professor The General Hospital of People's liberation Army

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02273050    
Other Study ID Numbers: D1680C00009
First Posted: October 23, 2014    Key Record Dates
Results First Posted: February 5, 2018
Last Update Posted: February 5, 2018
Last Verified: August 2017
Keywords provided by AstraZeneca:
Type 2 Diabetes Mellitus, Dipeptidyl-Peptidase 4 Inhibitors, Saxagliptin, Metformin, Endocrine System Diseases
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Saxagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action