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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01364428 |
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Date of registration:
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31/05/2011 |
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Primary sponsor: |
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Public title:
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Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus
BEGIN™ |
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Scientific title:
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A Trial Comparing the Efficacy and Safety of Two Different Formulations of Insulin Degludec in Subjects With Type 2 Diabetes Mellitus ("BEGIN™: COMPARE") |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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373 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01364428 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Hani Yassin |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Type 2 diabetes (diagnosed clinically) for minimum 24 weeks prior to randomisation
(visit 2)
- Current treatment with basal-only insulin (no prandial insulin) consisting of either
insulin detemir OD (once daily), insulin glargine OD or NPH insulin OD/BID for at
least 12 weeks prior to randomisation (visit 2), in combination with stable doses of
OAD(s) (metformin, insulin secretagogue (sulfonylurea or glinide), alpha-glucosidase
inhibitor, pioglitazone or dipeptidyl peptidase IV (DPP-IV inhibitor) in any approved
(according to label) dose or combination. Stable OAD doses are defined as unchanged
doses for at least 12 weeks prior to randomisation (visit 2)
- HbA1c (glycosylated haemoglobin) between 7.0-10.0% (both inclusive) by central
laboratory analysis
- BMI (Body Mass Index) below or equal to 45 kg/m^2
- Ability and willingness to adhere to the protocol including SMPG (self-measured
plasma glucose) according to the protocol
Exclusion Criteria:
- Treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit
2)
- Treatment with glucagon like peptide-1 (GLP-1) receptor agonists within the last 12
weeks prior to randomisation (visit 2)
- Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the
last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial
physician)
- Previous participation in this trial. Participation is defined as randomised.
Re-screening is allowed once during the recruitment period
- Known or suspected hypersensitivity to trial products or related products
- The receipt of any investigational drug within 4 weeks prior to randomisation (visit
2)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Intervention(s)
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Drug: insulin degludec
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Primary Outcome(s)
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Percentage change from baseline in HbA1c (glycosylated haemoglobin)
[Time Frame: Week 0, week 22]
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Secondary Outcome(s)
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Change in FPG (fasting plasma glucose)
[Time Frame: Week 0, week 22]
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Number of severe and minor treatment emergent hypoglycaemic episodes
[Time Frame: Weeks 0-23]
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Number of treatment emergent adverse events (TEAEs)
[Time Frame: Weeks -1-23]
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Secondary ID(s)
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NN1250-3923
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U1111-1119-2518
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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