Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• semaglutide — DRUG
  Once-daily oral administration as tablets.
• semaglutide — DRUG
  Once-weekly,injected s.c./subcutaneously (under the skin) using a pen
• oral placebo — DRUG
  Once-daily oral administration as tablets.

Study Details

This trial is conducted globally. The aim of the trial is to examine the dose range, escalation and efficacy of oral semaglutide in subjects with type 2 diabetes.

Key Dates

Start date

Dec 2, 2013

Status verified

Jan 2021

Primary completion

Dec 11, 2014

Completion

Dec 11, 2014

Study Design

Enrollment

632 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1:Semaglutide tablets : 2.5 mg
  2.5 mg for 26 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
• Experimental: 2:Semaglutide tablets: 2.5 mg/5 mg
  2.5 mg for 4 weeks, then 5.0 mg for 22 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
• Experimental: 3:Semaglutide tablets: 5.0 mg/10 mg
  5.0 mg for 4 weeks, then 10 mg for 22 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
• Experimental: 4:Semaglutide tablets:5.0 mg/10 mg/20 mg
  5.0 mg for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 18 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
• Experimental: 5:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg
  5.0 mg for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 4 weeks, then 40 mg for 14 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
• Experimental: 6:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg
  5.0 mg for 8 weeks, then 10 mg for 8 weeks, then 20 mg for 8 weeks, then 40 mg for 2 weeks All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
• Experimental: 7:Semaglutide tablets: 5.0 mg/10 mg/20 mg/40 mg
  5.0 mg for 2 weeks, then 10 mg for 2 weeks, then 20 mg for 2 weeks, then 40 mg for 20 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
• Placebo Comparator: 8:Placebo tablets
  All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
• Active Comparator: 9:Semaglutide injections :0.25 mg/0.50 mg/1.0 mg
  0.25 mg for 4 weeks, then 0.50 mg for 4 weeks, then 1.0 mg for 18 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

Primary Outcome Measure

Change in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 26 ]

Locations (40)

Find similar trials in Tucson, AZ

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