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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: semaglutide; Drug: oral placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01923181

NN9924-3790

U1111-1136-4716 (Other Identifier)

2012-004994-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 632 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI above or equal to 25 and below or equal to 40 kg/m^2
• Subjects diagnosed with T2D (Type 2 diabetes) treated with diet and exercise and/or who have been on a stable dose of metformin for at least 30 days prior to screening
• HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive)

Exclusion criteria

• Subjects on selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants
• History of chronic pancreatitis or idiopathic acute pancreatitis
• Chronic malabsorption, regardless of aetiology
• History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
• Treatment with glucose lowering agent(s) other than metformin as stated in the inclusion criteria in a period of 90 days before the screening visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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632 participants in 9 patient groups, including a placebo group

1:Semaglutide tablets : 2.5 mg

Experimental group

Description:

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.

Treatment:

Drug: semaglutide

Drug: semaglutide

2:Semaglutide tablets: 2.5 mg/5 mg

Experimental group

Description:

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.

Treatment:

Drug: semaglutide

Drug: semaglutide

3:Semaglutide tablets: 5.0 mg/10 mg

Experimental group

Description:

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.

Treatment:

Drug: semaglutide

Drug: semaglutide

4:Semaglutide tablets:5.0 mg/10 mg/20 mg

Experimental group

Description:

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.

Treatment:

Drug: semaglutide

Drug: semaglutide

5:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg

Experimental group

Description:

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.

Treatment:

Drug: semaglutide

Drug: semaglutide

6:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg

Experimental group

Description:

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.

Treatment:

Drug: semaglutide

Drug: semaglutide

7:Semaglutide tablets: 5.0 mg/10 mg/20 mg/40 mg

Experimental group

Description:

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.

Treatment:

Drug: semaglutide

Drug: semaglutide

8:Placebo tablets

Placebo Comparator group

Description:

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.

Treatment:

Drug: oral placebo

9:Semaglutide injections :0.25 mg/0.50 mg/1.0 mg

Active Comparator group

Description:

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.

Treatment:

Drug: semaglutide

Drug: semaglutide