NCT01162876

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of saxagliptin administered before breakfast for 14 consecutive days in patients with type 2 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_3 diabetes

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

Study Start

First participant enrolled

July 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

July 12, 2010

Last Update Submit

March 7, 2017

Conditions

Diabetes

Keywords

Diabetes, Type 2

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics

    Concentrations of plasma saxagliptin and BMS-510849

    daily, up to 42days

  • Pharmacodynamics

    Plasma DPP4 actyivity Concentrations of blood glucose, C-peptide, insulin and glucagon Plasma active GLP-1 concentration

    daily, up to 42 days

Secondary Outcomes (1)

  • Safety issues

    daily, up to 42 days

Study Arms (1)

saxagliptin

EXPERIMENTAL

5 mg daily for 14days

Drug: saxaglipitin

Interventions

saxaglipitinDRUG

oral administration of 5 mg tablet before breakfast for 14 consecutive days

saxagliptin

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who meet all of the following criteria will be included:
  • HbA1c level ≥7.0% and \< 9.0%
  • Fasting glucose level ≥130mg/dL and \<210mg/dL
  • Patients who are capable of giving informed consent
  • Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after completion of the study

You may not qualify if:

  • Patients with type 1 diabetes mellitus; patients with diabetes mellitus due to other specified drugs, mechanisms, or diseases; and patients with gestational diabetes mellitus
  • Patients with a medical history of diabetic coma
  • Patients with heart failure
  • Patients with a complication of active chronic hepatitis or hepatic cirrhosis
  • Patients undergoing treatment of glomerular diseases other than diabetic nephropathy
  • Patients with a history or complication of malignant tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyushu Clinical Pharmacology Reserch Clinic

Fukuoka, Japan

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2010

First Posted

July 15, 2010

Study Start

July 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations

JP(1)