Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes

NCT01204775 | Completed Phase 3 Results DMC

• 2 other identifiers: CV181-0582010-020360-38
• Study Type: interventional
• Target: 26
• Locations: 4 countries
• Sites: 16

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin in pediatric patients with type 2 diabetes.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Mean Change in HbA1c From Baseline to Week 16

  16 week short term treatment period

Study Arms (2)

Saxagliptin

EXPERIMENTAL

Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)

Drug: Saxagliptin; Drug: Metformin (Active Rescue)

Placebo

PLACEBO COMPARATOR

Placebo matching saxagliptin tablet

Drug: Placebo (Saxagliptin); Drug: Metformin IR; Drug: Placebo (Metformin); Drug: Metformin (Active Rescue)

Interventions

Saxagliptin DRUG

Tablets, Oral, 2.5 mg or 5.0 mg (according to body weight category), Once Daily, 1-52 weeks

Also known as: BMS-477118, Onglyza

Saxagliptin

Placebo (Saxagliptin) DRUG

Tablets, Oral, Once daily, 1-16 weeks

Placebo

Metformin IR DRUG

Tablets, Oral, 500 mg, Once Daily, 17-52 weeks

Placebo

Placebo (Metformin) DRUG

Tablets, Oral, Once daily, 1-16 weeks

Placebo

Metformin (Active Rescue) DRUG

Tablets, Oral, 500 mg, Titrated as needed, 2-52 weeks

Placebo; Saxagliptin

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female patients eligible if 10 years of age, up to 17 years and 32 weeks of age at the time of randomization, diagnosed as having type 2 diabetes prior to study enrollment.
• HbA1c ≥7.0% and ≤10.5%
• Body weight ≥ 30 kg.
• BMI \> 85th percentile
• Age and Reproductive Status a) Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. The decision for appropriate methods to prevent pregnancy should be determined by discussions between the investigator and the study subject.
• b) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product. c) Women must not be breastfeeding. d) Sexually active fertile men must use effective birth control if their partners are WOCBP.

You may not qualify if:

• Target Disease Exceptions
• a) Current use of the following medications for the treatment of diabetes, or use within the specified timeframe prior to screening for the study: i) Six months: insulin. ii) Four months: thiazolidinediones. iii) Two months: any other antidiabetic treatment iv) Any previous use of DPP4-inhibitor and/or incretin mimetics b) Current use of prescription or non-prescription weight loss drugs and their use within 3 months of screening.
• Medical History and Concurrent Diseases
• a) Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study (eg, current treatment for cancer). b) Previous diagnosis of monogenic etiology of type 2 diabetes such as MODY (maturity onset of diabetes in youth) or secondary diabetes (steroid use, Cushing's disease, acromegaly). c) Significant cardiovascular history. d) History of hemoglobinopathies (sickle cell anemia or thalassemias, sideroblastic anemia). e) History of unstable or rapidly progressive renal disease. f) History of alcohol or drug abuse. g) Psychiatric or cognitive disorder that will, in the opinion of investigators, limit the patient's ability to comply with the study medications and monitoring. h) Administration of any other study drug or participation in a clinical research trial within 30 days of planned enrollment to this study (or a longer period if dictated by local regulatory authorities). i) Any condition, which in the investigator's opinion may render the subject unable to complete the study or may pose significant risk to the subject. j) Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus. k) Subjects on a commercial weight loss program with ongoing weight loss, or on an intensive exercise program.
• Physical and Laboratory Test Findings a) Fasting plasma glucose (FPG) \> 255 mg/dL (14.2 mmol/L) at screening will exclude the patient. b) Diabetic ketoacidosis (DKA) within 6 months of study entr1) Target Disease Exceptions a) Current use of the following medications : i) Six months: insulin. ii) Four months: thiazolidinediones. iii) Two months: any other antidiabetic treatment iv) Any previous use of DPP4-inhibitor and/or incretin mimetics b) Current use of prescription or non-prescription weight loss drugs and their use within 3 months of screening.
• \) Medical History and Concurrent Diseases
• a) Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study (eg, current treatment for cancer). b) Previous diagnosis of monogenic etiology of type 2 diabetes such as MODY (maturity onset of diabetes in youth) or secondary diabetes (steroid use, Cushing's disease, acromegaly). c) Significant cardiovascular history. d) History of hemoglobinopathies (sickle cell anemia or thalassemias, sideroblastic anemia). e) History of unstable or rapidly progressive renal disease. f) History of alcohol or drug abuse. g) Psychiatric or cognitive disorder that will, in the opinion of investigators, limit the patient's ability to comply with the study medications and monitoring. h) Administration of any other study drug or participation in a clinical research trial within 30 days of planned enrollment to this study (or a longer period if dictated by local regulatory authorities). i) Any condition, which in the investigator's opinion may render the subject unable to complete the study or may pose significant risk to the subject. j) Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus. k) Subjects on a commercial weight loss program with ongoing weight loss, or on an intensive exercise program. 3) Physical and Laboratory Test Findings
• Fasting plasma glucose (FPG) \> 255 mg/dL (14.2 mmol/L) at screening
• Diabetic ketoacidosis (DKA) within 6 months of study entry (DKA can occur as a presenting sign of type 2 diabetes in youth).
• Abnormal renal function, which is defined as an abnormal creatinine clearance rate as determined by the Schwartz Formula
• Subjects who have contraindications to therapy as outlined in the Saxagliptin Investigator Brochure or local metformin package insert.
• Subjects with known contraindications to DPP-IV therapy. 5) Prohibited Therapies and/or Medications
• Prisoners or subjects who are involuntarily incarcerated.
• Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
• Employees of BMS, AstraZeneca (AZ), or their relatives.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (16)

Research Site

Los Angeles, California, United States

Location

Research Site

San Diego, California, United States

Location

Research Site

Hollywood, Florida, United States

Location

Research Site

Tallahassee, Florida, United States

Location

Research Site

Tampa, Florida, United States

Location

Research Site

Dearborn, Michigan, United States

Location

Research Site

Buffalo, New York, United States

Location

Research Site

Memphis, Tennessee, United States

Location

Research Site

Richmond, Virginia, United States

Location

Research Site

Moscow, Russia

Location

Research Site

Novosibirsk, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Cape Town, South Africa

Location

Research Site

Pretoria, South Africa

Location

Research Site

Taichung, Taiwan

Location

Research Site

Taipei, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Eva Johnsson, Clinical Science Lead, GLOBAL_MEDICINES_DEV
• Organization: AstraZeneca AB, S-151 85 Södertälje, Sweden

Eva.Johnsson@astrazeneca.com

+46 31 7762484

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 17, 2010
• Study Start: June 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 18, 2017
• Results First Posted: April 18, 2017

Record last verified: 2017-03

Locations

TW (2); ZA (2); US (9); RU (3)