Effect of GLP-1 on insulin dose, risk of hypoglycemia and gastric emptying in type 1 diabetes mellitus - GLP-1 in type 1 diabetes

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011930-80-DK

Enrollment

Registered

2009-06-02

Start date

2009-07-09

Completion date

Unknown

Last updated

2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes MedDRA version: 12.0 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent

Interventions

Trade Name: Victoza Product Name: Victoza Product Code: H-C-1026-00-00 Pharmaceutical Form: Suspension for injection INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656-20-2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 1 diabetes, age 18-55, BMI 18-27, no known disease complications Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Impaired kidney function, any other systemic disease anticipated to prevent the patient from completing the trial, haemoglobin below lower limit, Hba1c >= 8.5%, autonomous nerve dysfunction

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether treatment with GLP-1 affects insulin dose and 24-hours glucose profiles in patients with type 1 diabetes;Secondary Objective: To investigate whether treatment with GLP-1: 1) affects the risk of hypoglycemia, 2)affects the gastric emptying rate of hypoglycemia 3)results in weight changes 4)affects the glycemic control (HbA1c and fructosamin);Primary end point(s): Insulin dose (IE/day)	—

Measure

Time frame

Main Objective: To investigate whether treatment with GLP-1 affects insulin dose and 24-hours glucose profiles in patients with type 1 diabetes;Secondary Objective: To investigate whether treatment with GLP-1: 1) affects the risk of hypoglycemia, 2)affects the gastric emptying rate of hypoglycemia 3)results in weight changes 4)affects the glycemic control (HbA1c and fructosamin);Primary end point(s): Insulin dose (IE/day)

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026