Phase 2
Completed N=630
Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01923181 ↗Enrolled (actual)
630
Serious AEs
3.3%
Results posted
Nov 2019
Primary outcomePrimary: Change in HbA1c (Glycosylated Haemoglobin) — -0.88; -1.23; -1.56; -1.70 Percentage of HbA1c — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c (Glycosylated Haemoglobin) |
-0.88; -1.23; -1.56; -1.70; -2.04; -1.76 | <0.0001 sig |
| SECONDARY Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol) |
27; 50; 49; 41; 42; 47 | — |
| SECONDARY Change in Body Weight |
-2.01; -2.89; -4.90; -5.75; -6.91; -5.93 | — |
| SECONDARY Change in Waist Circumference |
-2.00; -2.29; -5.28; -4.08; -5.71; -4.86 | — |
| SECONDARY Change in Body Mass Index (BMI) |
-0.67; -0.98; -1.72; -1.93; -2.37; -2.04 | — |
| SECONDARY Number of Treatment Emergent Adverse Events (TEAEs) Recorded |
142; 169; 233; 289; 230; 233 | — |
| SECONDARY Number of Confirmed Hypoglycaemic Episodes Recorded |
4; 4; 6; 1; 1; 3 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01923181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.