Effect of three doses of nasal glp-1 versus placebo on postprandial hyperglycaemia in type 2 diabetes.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003760-38-DK

Enrollment

Registered

2005-09-05

Start date

2005-10-14

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

postprandial hyperglycaemia in type 2 diabetes Classification code 10045242

Interventions

Product Name: Glucagone Like Peptide Product Code: GLP-1 Pharmaceutical Form: Nasal powder Pharmaceutical form of the placebo: Nasal powder Route of administration of the placebo: Nasal use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age between 30 and 70 years old • Type 2 diabetes in accordance to WHO • Duration of diet or diet and metformin treatment > 3 months • HbA1c > 7.5 % and 0.3 nmol/l • Negative for ICA and GAD 65 • BMI between 25 and 35 kg/m2 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: • Subjects treated with the following medications during the last month: corticosteroids, hormones (except oestrogens) • Proliferative retinopathy • Known or suspected abuse of alcohol or narcotics • Subjects with hypoglycaemic unawareness • Recurrent major hypoglycaemia more than one time during the last one year. • Impaired hepatic function (ASAT or ALP > 2 times normal range) • Impaired renal function (Serum-creatinine > 150 micromol/l (1.7 mg/dl)) • Cardiac problems defined as: - Decompensated heart failure (NYHA class III or IV) - Unstable angina pectoris - Myocardial infarction within the last 12 months • Uncontrolled hypertension (systolic pressure > 180 mm Hg and/or diastolic pressure > 100 mm Hg) • Abnormal findings in the nasal cavity • Any condition that the investigator feels would interfere with trial participation. • Pregnancy, breastfeeding or intention of becoming pregnant or judge to be using an inadequate contraceptive measure. • Receiving any investigational drug within the last 3 months

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess and compare the efficacy of three different doses of nasal GLP-1 versus placebo on glycaemic control during a day including three meals.;Secondary Objective: The secondary objective is to assess and compare three doses of nasal GLP-1 versus placebo on: •Safety and tolerability (using the Gastrointestinal System Rating Scale (GRSR) on the four treatment days with three different doses. •Suppression of glucagon and free fatty acid •Beta-cell sensitivity to changes in glucose during the meal •Hypoglycaemic events ;Primary end point(s): •Changes in glucose control and in GLP-1 concentrations	—

Measure

Time frame

Main Objective: To assess and compare the efficacy of three different doses of nasal GLP-1 versus placebo on glycaemic control during a day including three meals.;Secondary Objective: The secondary objective is to assess and compare three doses of nasal GLP-1 versus placebo on: •Safety and tolerability (using the Gastrointestinal System Rating Scale (GRSR) on the four treatment days with three different doses. •Suppression of glucagon and free fatty acid •Beta-cell sensitivity to changes in glucose during the meal •Hypoglycaemic events ;Primary end point(s): •Changes in glucose control and in GLP-1 concentrations

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Countries

Denmark

Outcome results

None listed

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