A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01434186
• Collaborator: Bristol-Myers Squibb (Industry)
• Enrollment: 32
• Locations: 16
• Arms: 2
• Duration (Months): 47
• Patients Per Site: 2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Placebo matching with Saxagliptin; Drug: Metformin IR; Drug: Metformin XR; Drug: Saxagliptin	Phase 3

Detailed Description

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination with Metformin IR or Metformin XR in Pediatric Patients with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone or in Combination with Baseline Insulin Therapy

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1: Saxagliptin +Metformin XR/IR Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg	Drug: Metformin IR; Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52; Drug: Metformin XR; Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52; Drug: Saxagliptin; Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight); Other Names: BMS-477118
Placebo Comparator: Arm 2: Placebo +Metformin XR/IR Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg	Drug: Placebo matching with Saxagliptin; Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52; Drug: Metformin IR; Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52; Drug: Metformin XR; Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52

Outcome Measures

Primary Outcome Measures

1. Mean Change in HbA1c From Baseline to Week 16 [16 week short term treatment period]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male and female patients eligible if 10 years of age, up to 17 years and 30 weeks of age at the time of screening

• Previously diagnosed as having type 2 diabetes

• HbA1c ≥7.0% and ≤10.5%

• Body weight ≥ 30 kg

• Stable dose of metformin (≥ 1000mg - ≤ 2000mg) for a minimum of 2 months

• Women must have a negative serum or urine pregnancy test

• Women must not be breastfeeding

Exclusion Criteria:

• Current use of anti-diabetic medications or use within the specified timeframe prior to screening (Exception: Metformin)

• Fasting plasma glucose (FPG) > 255 mg/dL

• Diabetic ketoacidosis (DKA) within 6 months of study entry

• Abnormal renal function

• Active liver disease

• Anemia

• An abnormal Thyroid Stimulating Hormone (TSH)

• Creatinine kinase (CK) ≥ 3X ULN

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Los Angeles	California	United States
2	Research Site	Tallahassee	Florida	United States
3	Research Site	Dearborn	Michigan	United States
4	Research Site	St. Paul	Minnesota	United States
5	Research Site	Mineola	New York	United States
6	Research Site	Cleveland	Ohio	United States
7	Research Site	Memphis	Tennessee	United States
8	Research Site	Namur		Belgium
9	Research Site	Calgary	Alberta	Canada
10	Research Site	Bangalore		India
11	Research Site	Aguascalientes		Mexico
12	Research Site	Meridas		Mexico
13	Research Site	Monterrey		Mexico
14	Research Site	Veracruz		Mexico
15	Research Site	Taichung		Taiwan
16	Research Site	Leicester		United Kingdom

Sponsors and Collaborators

• AstraZeneca
• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01434186
• Other Study ID Numbers: CV181-147; 2010-024568-16
• First Posted: Sep 14, 2011
• Last Update Posted: Apr 18, 2017
• Last Verified: Mar 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metformin; Saxagliptin

Study Results

Participant Flow

Pre-assignment Detail	Of 32 subjects enrolled, 7 subjects entered the lead-in period. Of these 7 subjects, 6 were randomized

Arm/Group Title	Placebo	Saxagliptin
Arm/Group Description	Placebo matching saxagliptin	saxagliptin 2.5 or 5 mg according to body weight
Period Title: Overall Study
STARTED	2	4
COMPLETED	2	4
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Placebo	Saxagliptin	Total
Arm/Group Description	Placebo matching saxagliptin	saxagliptin 2.5 or 5 mg according to body weight	Total of all reporting groups
Overall Participants	2	4	6
Age (Count of Participants)
<=18 years	2 100%	4 100%	6 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	2 100%	4 100%	6 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Mean Change in HbA1c From Baseline to Week 16
Time Frame	16 week short term treatment period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Saxagliptin	Placebo
Arm/Group Description	Saxagliptin 2.5 mg or 5 mg according to bodyweight	Saxagliptin matching placebo
Measure Participants	4	2
Mean (Standard Deviation) [percentage]	-1.0 (0.62)	0.9 (0.14)

Adverse Events

Time Frame	52 week
Arm/Group Title	Placebo		Saxagliptin
Arm/Group Description	Placebo matching saxagliptin		saxagliptin 2.5 or 5 mg according to body weight
All Cause Mortality
	Placebo		Saxagliptin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Saxagliptin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Saxagliptin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		4/4 (100%)
Gastrointestinal disorders
ABDOMINAL PAIN UPPER	0/2 (0%)		1/4 (25%)
Infections and infestations
Pharyngitis Streptococcal	0/2 (0%)		1/4 (25%)
Pharyngitis	0/2 (0%)		1/4 (25%)
Pharyngitis bacterial	0/2 (0%)		1/4 (25%)
Injury, poisoning and procedural complications
LACERATION	1/2 (50%)		0/4 (0%)
Investigations
URINE OUTPUT INCREASED	1/2 (50%)		0/4 (0%)
Musculoskeletal and connective tissue disorders
Back pain	0/2 (0%)		1/4 (25%)
Nervous system disorders
Headache	0/2 (0%)	0	2/4 (50%)	3
Dizziness	0/2 (0%)		1/4 (25%)
Reproductive system and breast disorders
MENSTRUATION IRREGULAR	1/2 (50%)		0/4 (0%)
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN	0/2 (0%)		1/4 (25%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.