Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recent studies show that many Type 1 diabetes patients have remaining endogenous insulin production, albeit at low levels. Finding means to increase this production would be of tremendous interest, since residual C-peptide concentrations >0.1 nmol/l previously have been shown to markedly lower HbA1c, decrease blood glucose fluctuations and diminish the risk of ketoacidosis. It also substantially reduces the risks of severe hypoglycemic events and late complications. Liraglutide may through its incretin effect directly potentiate beta-cell function, but also holds the potential to be mitogenic for these cells.
The hypothesis of the present trial is that treatment with liraglutide will not only have a direct effect on beta-cell function, which is more or less immediately observed, but also progressively improve C-peptide concentrations over time.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide treatment | Active Comparator | Liraglutide treatment in the dose of 1.8 mg daily for 52 weeks |
|
| Placebo treatment | Placebo Comparator | Treatment with placebo once daily for 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | Treatment with liraglutide for 52 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of 52 weeks of treatment with liraglutide 1.8 mg/day, compared to placebo, on stimulated C-peptide concentrations in patients with long-standing type 1 diabetes and residual insulin production | The Area Under the Curve (AUC) change in plasma C-peptide concentration in response to a standardized mixed meal tolerance test (MMTT) during one year of liraglutide treatment (1.8 mg/day) | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in C-peptide between 6 and 52 weeks of study | ∆- change in C-peptide AUC between the MMTT after one year and that after 6 weeks of treatment | 52 weeks |
| Change in C-peptide between after and prior to treatment with liraglutide 1.8 mg |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Per-Ola Carlsson, MD, PhD | Uppsala University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala University Hospital | Uppsala | SE-75185 | Sweden |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo for liraglutide |
| Drug |
Placebo for liraglutide. Treatment once daily for 52 weeks |
|
∆-change in C-peptide AUC between the MMTT three months after cessation of treatment and that after the run-in period
| 52 weeks |
| Change in HbA1c between before and at end of liraglutide (1.8 mg) treatment | ∆- change in HbA1c between after one year and after the run-in period. | 52 weeks |
| Change in HbA1c between 6 and 52 weeks of study | ∆- change in HbA1c between after one year and after 6 weeks of treatment | 52 weeks |
| Change in HbA1c between after and prior to treatment with liraglutide 1.8 mg | ∆- change in HbA1c between three months after the cessation of treatment and after the run-in period. | 52 weeks |
| Change in insulin doses between before and at end of liraglutide (1.8 mg) treatment | ∆- change in exogenous insulin doses between after one year and after the run-in period. | 52 weeks |
| Change in insulin doses between 6 and 52 weeks of study | ∆- change in exogenous insulin doses between after one year and after 6 weeks of treatment | 52 weeks |
| Change in insulin doses between after and prior to treatment with liraglutide 1.8 mg | ∆- change in exogenous insulin doses between three months after the cessation of treatment and after the run-in period. | 52 weeks |
| Change in glucose variability between before and at end of liraglutide (1.8 mg) treatment | ∆- change in glucose variability between after one year and after the run-in period. | 52 weeks |
| Change in glucose variability between 6 and 52 weeks of study | ∆- change in glucose variability between after one year and after 6 weeks of treatment | 52 weeks |
| Change in glucose variability between after and prior to treatment with liraglutide 1.8 mg | ∆- change in glucose variability between three months after the cessation of treatment and after the run-in period. | 52 weeks |
| Change in hypoglycemia frequency between before and at end of liraglutide (1.8 mg) treatment | ∆- change in hypoglycemia frequency (measured plasma glucose levels < 3 mmol/l or assisted hypoglycemia during a one week period) between one year and after the run-in period. | 52 weeks |
| Change in hypoglycemia frequency between 6 and 52 weeks of study | ∆- change in hypoglycemia frequency (measured plasma glucose levels < 3 mmol/l or assisted hypoglycemia during a one week period) after one year and after 6 weeks of treatment | 52 weeks |
| Change in hypoglycemia frequency between after and prior to treatment with liraglutide 1.8 mg | ∆- change in hypoglycemia frequency (measured plasma glucose levels < 3 mmol/l or assisted hypoglycemia during a one week period) between three months after the cessation of treatment and after the run-in period. | 52 weeks |
| Change in Quality of Life (QoL) between before and at end of liraglutide (1.8 mg) | ∆- change in assessment of QoL between after one year and after the run-in period. | 52 weeks |
| Change in QoL between 6 and 52 weeks of study | ∆- change in assessment of QoL between after one year and after 6 weeks of treatment | 52 weeks |
| Change in QoL between after and prior to treatment with liraglutide | ∆- change in assessment of QoL between three months after the cessation of treatment and after the run-in period. | 52 weeks |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |