A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes

Conditions

• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Semaglutide — DRUG
  Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.
• Placebo (semaglutide) — DRUG
  Semaglutide placebo injected once-weekly from week 13 to week 40.

Study Details

This study compares the effect of two doses of semaglutide (1.0 mg and 2.0 mg) in people with type 2 diabetes (T2D). People taking part in the study will take the medicine together with their current diabetes medicine (sulphonylurea and/or metformin). Participants will get a dose of either 1.0 mg or 2.0 mg semaglutide once a week - which dose is decided by chance. Participants will inject semaglutide under the skin once a week. The study will last for about 49 weeks. Participants will have 9 clinic visits and 2 phone calls with the study doctor. At the visits participants will have blood taken and eye tests done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Female participants who can get pregnant will be checked 11 times for pregnancy via urine tests.

Key Dates

Start date

Jun 19, 2019

Status verified

Feb 2023

Primary completion

Sep 18, 2020

Completion

Nov 9, 2020

Study Design

Enrollment

961 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide 2.0 mg
  All participants will receive one injection per week during a 12-week dose escalation period, until the target dose for semaglutide 2.0 mg is reached. From week 13 to week 40, semaglutide will be given in two weekly injections of 1.0 mg each.
• Active Comparator: Semaglutide 1.0 mg
  All participants will receive one injection per week during a 12-week dose escalation period. From week 13 to week 40, the 1.0 mg group will receive an additional injection of semaglutide placebo in order to maintain the blinding.

Primary Outcome Measure

Change in HbA1c [ Time Frame: Week 0, week 40 ]

Locations (61)

Find similar trials in Birmingham, AL

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