A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With Type 2 Diabetes Mellitus

NCT07433062 | Suspended Phase 1

• 1 other identifier: D7860C00005
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants with Type 2 Diabetes Mellitus.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes; T2DM

Outcome Measures

Primary Outcomes (1)

• Mean glucose levels

  Mean glucose levels on Day 7 of each treatment period as assessed by Continuous Glucose Monitoring (CGM)

  Day 7

Secondary Outcomes (26)

• CGM Metric (Time in range)

  Day 7 of each treatment period

• CGM Metric (Time in tight range)

  Day 7 of each treatment period

• CGM Metric (time below range)

  Day 7 of each treatment period

• CGM Metric (time above range)

  Day 7 of each treatment period

• CGM Metric (AUC(0-24))

  Day 7 of each treatment period

Study Arms (2)

Treatment A

EXPERIMENTAL

AZD6793 and metformin

Drug: AZD6793

Treatment B

EXPERIMENTAL

Placebo and metformin

Drug: AZD6793 Placebo

Interventions

AZD6793 Placebo DRUG

Participants will receive oral doses of metformin with an interval of 12 hours between doses. The morning doses of metformin will be administered together with AZD6793 placebo (Treatment B).

Also known as: Placebo

Treatment B

AZD6793 DRUG

Participants will receive oral doses of metformin with an interval of 12 hours between doses. The morning doses of metformin will be administered together with AZD6793 (Treatment A).

Also known as: Active

Treatment A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician-diagnosis of T2DM
• On a stable dose of metformin 2000 mg per day for at least 3 months prior to screening.
• stable glycaemic control indicated by no change in treatment for diabetes within 3 months prior to screening
• HbA1c (Hemoglobin A1c) ≤ 8.5% at screening
• Body Mass Index (BMI) within the range 18.5 to 35 kg/m2 , inclusive, at screening.

You may not qualify if:

• Physician diagnosis of type 1 diabetes.
• History of any clinically important disease or disorder.
• History or presence of chronic Gastrointestinal, hepatic, renal, or pancreatic disease
• History of Human immunodeficiency viruses (HIV) infection or a positive HIV test.
• History of prior episode(s) of lactic acidosis.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators, site staff, sponsor and their representatives will remain blinded to each participant's assigned study intervention throughout the course of the study. In order to maintain this blind, an otherwise uninvolved 3rd party will be responsible for the reconstitution and dispensation of all study intervention and will endeavor to ensure that there are no differences in time taken to dispense following randomization.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Potential participants will be screened to assess their eligibility to enter the study up to 21 days prior to the start of the 14-day outpatient run-in period. Eligible participants will return to the study site for an outpatient visit on Day -14 and enter a 14-day outpatient run-in period. During this period they will receive metformin twice a day. Upon completion of the metformin run-in period, eligible participants will be admitted to the study site on Day -1 of Period 1 and randomized on Day 1 of Period 1 in a 1:1 ratio to one of two treatment sequences, AB or BA. AB being the test compound with metformin first and then metformin alone. BA being metformin alone first and then metformin with the test compound following their respective washout periods. After completion of Day 8 of Period 2, participants will receive a follow-up phone call about 5 days after their discharge.

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: February 25, 2026
• Study Start: January 14, 2026
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): June 18, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

DE (1)