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Completed

NCT Number: NCT01135992

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Clinical Trial Call Center, Goodyear, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin degludec

Drug

Individually adjusted insulin degludec administered three times weekly with continued unchanged pre-trial OAD (oral anti-diabetic drug) treatment for 12 weeks

insulin glargine

Drug

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 outcomes

  1. HbA1c (Glycosylated Haemoglobin)

    Time frame: Week 4 and Week 16

    HbA1C at week 4 and 16

Secondary outcomes

  1. Fasting Plasma Glucose (FPG)

    Time frame: Week 4 and Week 16

    FPG at week 4 and 16

  2. Change in Body Weight

    Time frame: Week 0, Week 4, Week 16

    Change from baseline in body weight after week 4 and after week 16

  3. Rate of Treatment Emergent Adverse Events (AEs)

    Time frame: 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

  4. Rate of Confirmed Hypoglycaemic Episodes

    Time frame: 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.

  5. Rate of Nocturnal Confirmed Hypoglycaemic Episodes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial Assessing the Implications of Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™: SIMPLIFY)

Acronym: BEGIN™

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 3, 2010
Registry last updated
Jan 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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