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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
insulin degludec
insulin glargine
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

IGlar/IDeg

IDeg 3TW

Arm Description

Outcomes

Primary Outcome Measures

HbA1c (Glycosylated Haemoglobin)
HbA1C at week 4 and 16

Secondary Outcome Measures

Fasting Plasma Glucose (FPG)
FPG at week 4 and 16
Change in Body Weight
Change from baseline in body weight after week 4 and after week 16
Rate of Treatment Emergent Adverse Events (AEs)
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
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
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.

Full Information

First Posted
May 31, 2010
Last Updated
December 14, 2015
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01135992
Brief Title
Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™)
Acronym
BEGIN™
Official Title
A Trial Assessing the Implications of Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™: SIMPLIFY)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IGlar/IDeg
Arm Type
Experimental
Arm Title
IDeg 3TW
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Individually adjusted insulin degludec administered three times weekly with continued unchanged pre-trial OAD (oral anti-diabetic drug) treatment for 12 weeks
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
Subjects continue their pre-trial insulin glargine once daily plus OAD (oral anti-diabetic drug) treatment for four weeks before switch to insulin degludec
Primary Outcome Measure Information:
Title
HbA1c (Glycosylated Haemoglobin)
Description
HbA1C at week 4 and 16
Time Frame
Week 4 and Week 16
Secondary Outcome Measure Information:
Title
Fasting Plasma Glucose (FPG)
Description
FPG at week 4 and 16
Time Frame
Week 4 and Week 16
Title
Change in Body Weight
Description
Change from baseline in body weight after week 4 and after week 16
Time Frame
Week 0, Week 4, Week 16
Title
Rate of Treatment Emergent Adverse Events (AEs)
Description
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
Time Frame
Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)
Title
Rate of Confirmed Hypoglycaemic Episodes
Description
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.
Time Frame
Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)
Title
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Description
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.
Time Frame
Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85395
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262-6972
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70002
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006-2930
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052-2649
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Dover
State/Province
New Hampshire
ZIP/Postal Code
03820
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03063
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755-8050
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Melrose Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224-2215
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76113
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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