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

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• Diabetes Mellitus 10,925
• Diabetes Mellitus, Type 2 9,359

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 632 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Study 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Drug: semaglutide

Interventions

• Drugsemaglutide

  Once-daily oral administration as tablets.

• Drugsemaglutide

  Once-weekly,injected s.c./subcutaneously (under the skin) using a pen

• Drugoral placebo

  Once-daily oral administration as tablets.

Primary outcomes

1. Change in HbA1c (Glycosylated Haemoglobin)

   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.

   Time frame: Week 0, week 26

Secondary outcomes

1. Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol)

   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.

   Time frame: After 26 weeks of treatment

2. Change in Body Weight

   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.

   Time frame: Week 0, Week 26

3. Change in Waist Circumference

   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.

   Time frame: Week 0, week 26

4. Change in Body Mass Index (BMI)

   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.

   Time frame: Week 0, week 26

5. Number of Treatment Emergent Adverse Events (TEAEs) Recorded

   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.

   Time frame: Weeks 0-31

6. Number of Confirmed Hypoglycaemic Episodes Recorded

   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.

   Time frame: Weeks 0-31

Baseline characteristics

Publications

• Davies M, Pieber TR, Hartoft-Nielsen ML, Hansen OKH, Jabbour S, Rosenstock J. Effect of Oral Semaglutide Compared With Placebo and Subcutaneous Semaglutide on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2017 Oct 17;318(15):1460-1470. doi: 10.1001/jama.2017.14752. PubMed 29049653 ↗

Related links

• Clinical Trials at Novo Nordisk ↗

Study documents

• Study protocol · Aug 24, 2016
• Statistical analysis plan · Jul 1, 2015

Documents are hosted by the registry — open the source record to download them.