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Clinical Trial Details

Trial ID: L2690
Source ID: NCT02229240
Associated Drug: Albiglutide
Title: Albiglutide Versus Placebo Added-on to Basal-Bolus Insulin Therapy in Subjects With Type 2 Diabetes Mellitus
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Albiglutide|DRUG: Matching albiglutide placebo
Outcome Measures: Primary: Percentage of subjects with severe or documented symptomatic hypoglycemia through Week 26, Severe hypoglycemia is defined as requiring third-party intervention. Documented symptomatic hypoglycaemia is defined as typical symptoms of hypoglycemia with an accompanying plasma glucose concentration \<=70 milligram (mg) per decilitre (dL) (\<=3.9 millimole per liter \[mmol/L\])., Up to Week 26|Change from baseline in glycosylated hemoglobin (HbA1c) at Week 26, Week 26 | Secondary: Change from baseline in body weight at Week 26 and over time, Up to Week 26|Total daily insulin dose, basal insulin dose and bolus insulin dose at Week 26 and over time, Up to Week 26|HbA1c change from baseline in over time, Up to Week 26|Fasting plasma glucose (FPG) change from Baseline at Week 26 and over time, Up to Week 26|Proportion of subjects achieving a HbA1c <7.0% and < 6.5% at Week 26 and over time, Up to Week 26|Percentage of subjects achieving HbA1c <7.0% without weight gain after 26 weeks of treatment, Up to Week 26|Percentage of subjects achieving HbA1c <7.0% without severe or documented symptomatic hypoglycemia after 26 weeks of treatment, Up to Week 26|Percentage of subjects achieving HbA1c <7.0% without weight gain and without severe or documented hypoglycemia after 26 weeks of treatment, Up to Week 26|Number of subjects with non-serious adverse events (AE), serious adverse events (SAE), and AEs and SAEs leading to discontinuation, Up to Week 30|Incidence of hypoglycemic events, Up to Week 30|Assessment of clinical laboratory tests, lipids, vital signs, ECGs and physical examinations, Up to Week 30
Sponsor/Collaborators: Sponsor: GlaxoSmithKline | Collaborators: PPD DEVELOPMENT, LP
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-08
Completion Date: 2015-12
Results First Posted:
Last Update Posted: 2016-01-11
Locations:
URL: https://clinicaltrials.gov/show/NCT02229240