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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01923181
First received: August 13, 2013
Last updated: April 24, 2014
Last verified: April 2014

August 13, 2013
April 24, 2014
December 2013
December 2014   (final data collection date for primary outcome measure)
Change in HbA1c (Glycosylated haemoglobin)) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01923181 on ClinicalTrials.gov Archive Site
  • Subjects who achieve (yes/no) HbA1c below 7 percent (53 mmol/mol) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
  • Change in waist circumference [ Time Frame: week 0, week 26 ] [ Designated as safety issue: No ]
  • Change in body mass index (BMI) [ Time Frame: week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of treatment emergent adverse events (TEAEs) recorded [ Time Frame: Weeks 0-31 ] [ Designated as safety issue: No ]
  • Number of confirmed hypoglycaemic episodes recorded [ Time Frame: Weeks 0-31 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes
Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: semaglutide
    Once-daily oral administration as tablets.
  • Drug: semaglutide
    Once-weekly,injected s.c./subcutaneously (under the skin) using a pen
  • Drug: oral placebo
    Once-daily oral administration as tablets.
  • 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.
    Intervention: Drug: semaglutide
  • 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.
    Intervention: Drug: semaglutide
  • 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.
    Intervention: Drug: semaglutide
  • 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.
    Intervention: Drug: semaglutide
  • 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.

    Intervention: Drug: semaglutide
  • 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.
    Intervention: Drug: semaglutide
  • 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.

    Intervention: Drug: semaglutide
  • 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.
    Intervention: Drug: oral placebo
  • 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.
    Intervention: Drug: semaglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
603
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Bulgaria,   Canada,   Denmark,   Germany,   Israel,   Italy,   Malaysia,   Serbia,   South Africa,   Spain,   Sweden,   United Kingdom
 
NCT01923181
NN9924-3790, 2012-004994-16, U1111-1136-4716
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP