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Investigate the Effect of AZD1656 on the Pharmacokinetics of Sitagliptin in Patients With Type 2 Diabetes Mellitus

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: AZD1656
Drug: Sitagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01095991
D1020C00032

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of AZD1656 on Sitagliptin pharmacokinetics and vice versa in patients with Type 2 Diabetes Mellitus.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with confirmed type 2 diabetes mellitus for at least 2 months and treated with metformin.
  • Body mass index between ≥19 and ≤42 kg/m2.

Exclusion criteria

  • Intake of another investigational drug within the last 30 days prior to enrolment.
  • Clinically significant illness or clinically relevant trauma.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

12 participants in 2 patient groups

1
Experimental group
Description:
AZD1656, day 1-5, AZD1656 + Sitagliptin day 6-10, Sitagliptin day 11-15.
Treatment:
Drug: AZD1656
Drug: Sitagliptin
2
Experimental group
Description:
Sitagliptin day 1-5, AZD1656 + Sitagliptin day 6-10, AZD1656 day 11-15.
Treatment:
Drug: AZD1656
Drug: Sitagliptin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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