Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™)

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin glargine; Drug: insulin degludec

• Registration Number: NCT01135992
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this clinical trial is to assess the implications of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in subjects with type 2 diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-31
• Study First Submitted QC: 2010-05-31
• Study Start: 2010-06
• Study First Posted: 2010-06-03
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Disposition First Submitted: 2011-02-24
• Disposition First Submitted QC: 2011-03-09
• Disposition First Posted: 2011-03-18
• Results First Submitted: 2015-10-16
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-14
• Last Update Submitted: 2015-12-14
• Results First Posted: 2016-01-22
• Last Update Posted: 2016-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

• Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
• HbA1c maximum 10 % by central laboratory analysis
• Current treatment with basal-oral therapy (BOT) (no prandial insulin ever) consisting of: at least three months with insulin glargine once daily (average prescribed dose must have been unchanged (within plus/minus 10%) for four weeks prior to Visit 1 as confirmed by patient records or verbal confirmation by the subject) in combination with stable (unchanged doses for at least 3 months prior to Visit 1) OAD (metformin, insulin secretagogues, pioglitazone, sitagliptin or alpha-glucosidase-inhibitor) treatment in any approved (according to label) dose or combination

Exclusion Criteria

• Use within the last three months prior to Visit 1 of: Exenatide, Liraglutide or Thiazoledinediones (TZDs) other than Pioglitazone
• Cardiovascular disease (CVD) defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty within the last six months prior to Visit 1
• Recurrent severe hypoglycaemia (more than one severe hypoglycaemic episode during the last 12 months), or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous six months
• Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
• Previous participation in this trial. Participation is defined as started on trial medication. Rescreening of screening failures is allowed only once within the limits of the recruitment period
• Known or suspected hypersensitivity to trial products or related products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IGlar/IDeg	insulin glargine	-
IDeg 3TW	insulin degludec	-

Primary Outcome Measures

Name	Time	Method
HbA1c (Glycosylated Haemoglobin)	Week 4 and Week 16	HbA1C at week 4 and 16

Secondary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose (FPG)	Week 4 and Week 16	FPG at week 4 and 16
Change in Body Weight	Week 0, Week 4, Week 16	Change from baseline in body weight after week 4 and after week 16
Rate of Treatment Emergent Adverse Events (AEs)	Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)	Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect
Rate of Confirmed Hypoglycaemic Episodes	Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)	Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L.
Rate of Nocturnal Confirmed Hypoglycaemic Episodes	Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)	Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.

Trial Locations

Locations (1)

Novo Nordisk Clinical Trial Call Center; 🇺🇸 Olympia, Washington, United States