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

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ClinicalTrials.gov Identifier: NCT01923181
Recruitment Status : Completed
First Posted : August 15, 2013
Results First Posted : November 5, 2019
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: semaglutide Drug: oral placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 632 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes
Actual Study Start Date : December 2, 2013
Actual Primary Completion Date : December 11, 2014
Actual Study Completion Date : December 11, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: semaglutide
Once-daily oral administration as tablets.
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.
 Drug: semaglutide
Once-daily oral administration as tablets.
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.
 Drug: semaglutide
Once-daily oral administration as tablets.
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.
 Drug: semaglutide
Once-daily oral administration as tablets.
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.

 Drug: semaglutide
Once-daily oral administration as tablets.
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.
 Drug: semaglutide
Once-daily oral administration as tablets.
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.

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


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 26 ]
    Change from baseline (week 0) in HbA1c was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.


Secondary Outcome Measures :
  1. Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol) [ Time Frame: After 26 weeks of treatment ]
    Participants who achieved HbA1c <7.0%, was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.

  2. Change in Body Weight [ Time Frame: Week 0, Week 26 ]
    Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.

  3. Change in Waist Circumference [ Time Frame: Week 0, week 26 ]
    Change from baseline (week 0) in waist circumference was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.

  4. Change in Body Mass Index (BMI) [ Time Frame: Week 0, week 26 ]
    Change from baseline (week 0) in body mass index (BMI) was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.

  5. Number of Treatment Emergent Adverse Events (TEAEs) Recorded [ Time Frame: Weeks 0-31 ]
    TEAEs were recorded during weeks 0-31 (26 weeks treatment period+5 weeks follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

  6. Number of Confirmed Hypoglycaemic Episodes Recorded [ Time Frame: Weeks 0-31 ]
    Treatment-emergent confirmed hypoglycaemic episodes were recorded during weeks 0-31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Confirmed hypoglycaemic episode is an episode that is severe according to the American Diabetes Association (ADA) classification or plasma glucose value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923181


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  Study Documents (Full-Text)

Documents provided by Novo Nordisk A/S:
Study Protocol  [PDF] August 24, 2016
Statistical Analysis Plan  [PDF] July 1, 2015

More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01923181    
Other Study ID Numbers: NN9924-3790
2012-004994-16 ( EudraCT Number )
U1111-1136-4716 ( Other Identifier: WHO )
First Posted: August 15, 2013    Key Record Dates
Results First Posted: November 5, 2019
Last Update Posted: January 15, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases