| Trial ID: | L6001 |
| Source ID: | NCT02113332
|
| Associated Drug: |
Liraglutide
|
| Title: |
Addition of Liraglutide to Patients With Type 2 Diabetes Treated With Multiple Daily Insulin Injections
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Liraglutide|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in HbA1c from baseline to week 24., Baseline, week 24 | Secondary: Change in weight from baseline to week 24, Baseline, week 24|Change in fasting glucose from baseline to week 24, Baseline, week 24|Change in the standard deviation of CGM from the run-in period to week 23-24, Run-in period, week 23-24|Change in mean glucose levels on CGM from the run-in period to week 23-24, Run-in period, week 23-24|Change in 1.5 hour postprandial glucose levels on capillary glucose measurements from the run-in period to week 23-24, Run-in period, week 23-24|Change in the score of the DTSQs from baseline to week 24, Baseline, week 24|Score of the DTSQc at week 24, Week 24|Proportion of patients with HbA1c less than 8.0% (64 mmol/mol) at week 24, Week 24|Proportion of patients with HbA1c less than 7.5% (58 mmol/mol) at week 24, Week 24|Change in total insulin dose from baseline to week 24, Baseline, week 24|Proportion of patients with HbA1c less than 7.0% (53 mmol/mol) at week 24, Week 24|Change in blood pressure from baseline to week 24, Baseline, week 24|Frequency of non-severe documented symptomatic hypoglycaemia (plasma glucose [PG] less than 4.0 mmol/l) from baseline to week 24, Baseline, week 24|Frequency of asymptomatic non-severe hypoglycaemia (PG less than 4.0 mmol/l) from baseline to week 24, Baseline, week 24|Frequency of non-severe documented symptomatic hypoglycaemia (PG less than 3.0 mmol/l) from baseline to week 24, Baseline, week 24|Frequency of asymptomatic non-severe hypoglycaemia (PG less than 3.0 mmol/l) from baseline to week 24, Baseline, week 24|Frequency of severe hypoglycaemia from baseline to week 24, Baseline, week 24|Change in blood lipid levels from baseline to week 24, Baseline, week 24
|
| Sponsor/Collaborators: |
Sponsor: Vastra Gotaland Region | Collaborators: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
124
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-01
|
| Completion Date: |
2014-08
|
| Results First Posted: |
|
| Last Update Posted: |
2015-02-03
|
| Locations: |
Falu Hospital, Falun, Sweden|Clicical Trial Center Sahlgrenska, Gothenburg, Sweden|Halmstad Hospital, Halmstad, Sweden|Helsingborg Hospital, Helsingborg, Sweden|Öbacka Clinic, Härnösand, Sweden|Lindsdals Health Center, Kalmar, Sweden|Karlskoga Hospital, Karlskoga, Sweden|Kristianstad Hospital, Kristianstad, Sweden|Kungsbacka Hospital, Kungsbacka, Sweden|Malmö University Hospital, Malmö, Sweden|CityDiabetes Clinic, Stockholm, Sweden|NU-Hospital Organization, Uddevalla, Sweden|Värnamo Hospital, Värnamo, Sweden|Ängelholm Hospital, Ängelholm, Sweden
|
| URL: |
https://clinicaltrials.gov/show/NCT02113332
|
