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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01135992
First received: May 31, 2010
Last updated: December 14, 2015
Last verified: December 2015

May 31, 2010
December 14, 2015
June 2010
November 2010   (final data collection date for primary outcome measure)
HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 4 and Week 16 ] [ Designated as safety issue: No ]
HbA1C at week 4 and 16
Change in HbA1c [ Time Frame: after 12 weeks of insulin degludec treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01135992 on ClinicalTrials.gov Archive Site
  • Fasting Plasma Glucose (FPG) [ Time Frame: Week 4 and Week 16 ] [ Designated as safety issue: No ]
    FPG at week 4 and 16
  • Change in Body Weight [ Time Frame: Week 0, Week 4, Week 16 ] [ Designated as safety issue: No ]
    Change from baseline in body weight after week 4 and after week 16
  • Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW) ] [ Designated as safety issue: No ]
    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.
  • Change in fasting plasma glucose (FPG) [ Time Frame: after 12 weeks of insulin degludec treatment ] [ Designated as safety issue: No ]
  • Change in Body Weight [ Time Frame: after 12 weeks of insulin degludec treatment ] [ Designated as safety issue: No ]
  • Number of treatment emergent adverse events (AEs) [ Time Frame: weeks 0-4, weeks 4-16 ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Time Frame: weeks 0-4, weeks 4-16 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™)
A Trial Assessing the Implications of Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™: SIMPLIFY)
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin degludec
    Individually adjusted insulin degludec administered three times weekly with continued unchanged pre-trial OAD (oral anti-diabetic drug) treatment for 12 weeks
  • Drug: insulin glargine
    Subjects continue their pre-trial insulin glargine once daily plus OAD (oral anti-diabetic drug) treatment for four weeks before switch to insulin degludec
  • Experimental: IGlar/IDeg
    Intervention: Drug: insulin glargine
  • Experimental: IDeg 3TW
    Intervention: Drug: insulin degludec
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
143
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01135992
NN1250-3839, U1111-1114-8802
No
Not Provided
Not Provided
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
December 2015

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