NCT01365091

Brief Summary

To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with saxagliptin, 5-mg and metformin, 500-mg XR tablets administered together in both the fasted and fed states. In addition, to demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin XR, 1000-mg, FDC tablet with saxagliptin, 5-mg and metformin, 1000-mg XR tablets administered together in both the fasted and fed states.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P75+ for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2011

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 19, 2013

Completed
Last Updated

May 8, 2015

Status Verified

April 1, 2015

Enrollment Period

5 months

First QC Date

May 16, 2011

Results QC Date

March 20, 2013

Last Update Submit

April 21, 2015

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

  • Maximum Observed Concentrations (Cmax) of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets

    Days 1, 2, and 3 of Periods 1 and 2

  • AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets

    AUC=Area under the concentration-time curve

    Days 1, 2, and 3 of Periods 1 and 2

  • AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf]) for Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets

    AUC=Area Under the Concentration-time Curve

    Days 1, 2, and 3 of Periods 1 and 2

Secondary Outcomes (1)

  • Number of Participants With Death as Outcome and Serious Adverse Events (SAEs)

    Continuously, from screening through Day 1 to within 30 days of drug discontinuation on Day 1

Study Arms (4)

Arm 1: Treatments A,B/B,A

EXPERIMENTAL

Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days. Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A).

Drug: Saxagliptin/metformin fixed-dose combination (FDC)Drug: SaxagliptinDrug: Metformin extended-release (XR)

Arm 2: Treatments C,D/D,C

EXPERIMENTAL

Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days. Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C).

Drug: Saxagliptin/metformin fixed-dose combination (FDC)Drug: SaxagliptinDrug: Metformin extended-release (XR)

Arm 3: Treatments E, F/F,E

EXPERIMENTAL

Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days. Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E).

Drug: SaxagliptinDrug: Saxagliptin/Metformin FDCDrug: Metformin

Arm 4: Treatments G,H/H,G

EXPERIMENTAL

Period 1: Participants received a single oral dose of saxagliptin , 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days. Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G).

Drug: SaxagliptinDrug: Saxagliptin/Metformin FDCDrug: Metformin

Interventions

Saxagliptin/metformin fixed-dose combination (FDC)DRUG

Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day

Also known as: Onglyza/Glucophage extended release (XR)
Arm 1: Treatments A,B/B,AArm 2: Treatments C,D/D,C
SaxagliptinDRUG

Tablet, oral, 5 mg, once on Day 1 only, 1 day

Also known as: Onglyza
Arm 1: Treatments A,B/B,AArm 2: Treatments C,D/D,CArm 3: Treatments E, F/F,EArm 4: Treatments G,H/H,G
Metformin extended-release (XR)DRUG

Tablet, oral, 500 mg, once on Day 1 only, 1 day

Also known as: Glifage XR
Arm 1: Treatments A,B/B,AArm 2: Treatments C,D/D,C
Saxagliptin/Metformin FDCDRUG

Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day

Also known as: Onglyza/Glucophage XR
Arm 3: Treatments E, F/F,EArm 4: Treatments G,H/H,G
MetforminDRUG

Tablet, oral, 1000 mg, once on Day 1 only, 1 day

Also known as: Glifage XR
Arm 3: Treatments E, F/F,EArm 4: Treatments G,H/H,G

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women
  • women of childbearing potential who are using acceptable method of contraception
  • Women who are not pregnant or nursing
  • Body Mass Index (BMI) of 18 to 29.9 kg/m\^2, inclusive. BMI=weight(kg)/height(m)\^2.

You may not qualify if:

  • Any significant acute or chronic medical illness.
  • History of gastrointestinal (GI) disease
  • Major surgery within 4 weeks of study drug administration
  • Any GI surgery that could impact study drug absorption
  • Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within the 6 months of study drug administration.
  • Blood transfusion within 3 months of study drug administration for women and within 2 months for men
  • Inability to be venipunctured and/or tolerate venous access
  • Current smoker or recent (within 1 month) history of regular tobacco use
  • Recent (within 6 months of study drug administration) drug or alcohol abuse
  • Participation in a bioequivalence study within the last 6 months of study drug administration
  • Estimated creatinine clearance of \<80 mL/min using Cockcroft-Gault formula
  • History of allergy to drug class or related compounds
  • History of allergy to metformin or other similar acting agents
  • History of any significant drug allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Campinas, São Paulo, 13073, Brazil

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptinMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Boaz Hirschberg
Organization
AstraZeneca Pharmaceuticals
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2011

First Posted

June 3, 2011

Study Start

June 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

May 8, 2015

Results First Posted

August 19, 2013

Record last verified: 2015-04

Locations

BR(1)