Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus.

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• semaglutide — DRUG
  Oral administration once-daily.
• sitagliptin — DRUG
  Oral administration once-daily.

Study Details

This trial is globally conducted. The aim of this trial is to investigate Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation versus Sitagliptin in Subjects with Type 2 Diabetes Mellitus.

Key Dates

Start date

Sep 20, 2016

Status verified

Jul 2022

Primary completion

Feb 28, 2018

Completion

Mar 27, 2019

Study Design

Enrollment

504 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide flexible dosing (3, 7 or 14 mg)
• Active Comparator: Sitagliptin 100 mg

Primary Outcome Measure

Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) [ Time Frame: Week 52 ]

Locations (37)

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