DelfaGLP-1 Atlas

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CompletedPhase 2

Investigating the Effect of Liraglutide on the Endogenous Glucose Production During in Tye 1 Diabetes Subjects

A Randomized, Double Blind, Two-period Cross-over Trial Investigating the Effect of Liraglutide as Add on to Intensive Insulin Treatment on the Endogenous Glucose Production in Subjects With C-peptide Positive Type 1 Diabetes Mellitus

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

14

actual

Study population

Type 1 diabetes

Key I/E criterion

•BMI 20-25

Primary endpoint

•Area under the curve of the endogenous glucose production from (=EGP)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02408705
Org study IDLG_T1_EGP

Timeline

Milestones

Study first posted2015-04-03estimated
Last update posted2016-09-12estimated
Study start2015-01 (month precision)
Primary completion2016-05actual (month precision)
Study completion2016-05actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial

2. Type 1 diabetes mellitus as diagnosed (including I - III):

i.history of type 1 diabetes mellitus manifestation with acute hyperglycaemia and ketonuria
ii.positive results for at least one of four islet antibodies (glutamic acid decarboxylase, protein tyrosine phosphatase, zinc transporter 8, or islet cell antibodies)
iii.residual basal fasting C-peptide of ≥ 0.1 nmol/L

3. Male or female, aged 18 - 64 years (both inclusive)

4. Body mass index (BMI) 20.0 - 25.0 kg/m2 (both inclusive)

5. HbA1c 42 - 80 mmol/mol (6.0-9.5%)

6. Treated with daily insulin injections or continuous s.c. insulin infusion (CSII) ≥ 1 months. Stable insulin dose as judged by the investigator

Exclusion criteria

1. Known or suspected hypersensitivity to trial product(s) or related products

2. Use of liraglutide or exenatide within 3 months before screening

3. Severe hypoglycaemia within 1 month of screening

4. Hypoglycaemia unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 2 months

5. Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis or coagulation screening tests, as judged by the investigator and any of the following laboratory safety results:

–Aspartate transaminase(=AST), alanine aminotransferase (=ALT), lipase, alkaline phosphatase > 2.0 times upper limit of reference range (ULN)
–Haemoglobin < 8.0 mmol/L (male) or < 6.4 mmol/L (female), total leukocyte count <3.0 x 109/L, thrombocytes <100 x 109/L
–Serum creatinine levels ≥ 126 μmol/L (male) or ≥ 111 μmol/L (female)
–Amylase outside normal range

6. Screening calcitonin > 50 ng/L

7. Personal history of non-familial medullary thyroid carcinoma

8. History of chronic or idiopathic acute pancreatitis Suffer from or history of a life threatening disease (e.g. cancer except basal cell skin cancer or squamous cell skin cancer), or any clinically significant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of diabetes mellitus and euthyroid struma), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders as judged by the investigator.

9. Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator.

10. Any disease or condition that, in the opinion of the investigator, would represent an unacceptable risk for the subject's safety.

11. Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator.

12. Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive methods include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner).

13. Severe acute and/or chronic diseases

Endpoints (19)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
9
Other (unclassified)
7
Safety / tolerability / PK
3

Glycemic / diabetes

9 endpoints
Primary/protocol endpoint/low confidence

Area under the curve of the endogenous glucose production from (=EGP) from begin of the hypoglycaemic clamp 5.5 mmol/L period until the end of recovery period (4.0 mmol/L), calculated from stable isotope labelled plasma glucose

Time frame:After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)

descriptive

Secondary/protocol endpoint/low confidence

Area under the curve of peripheral glucose uptake (=PGU), calculated from labelled PG from begin of the hypoglycaemic clamp period 5.5mmol/L until end of recovery period (4.0 mmol/L)

Time frame:After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)

descriptive, improvement

Secondary/protocol endpoint

Area under the glucose infusion rate curve from begin of the hypoglycaemic clamp period 5.5mmol/L until end of recovery period (4.0 mmol/L)

Time frame:After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)

descriptive

Secondary/protocol endpoint

Area under the glucose curve during the Mixed Meal Tolerance Test

Time frame:Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Area under the c-peptid concentration curve during the Mixed Meal Tolerance Test

Time frame:Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

Area under the insulin curve during the Mixed Meal Tolerance Test

Time frame:Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)

descriptive

Secondary/protocol endpoint/low confidence

Area under the glucagon curve during the Mixed Meal Tolerance Test

Time frame:Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)

change from baseline, improvement

Secondary/protocol endpoint

Change in HbA1c during each period detected by blood (fasting) at the begin of the visits and measured by a laboratory (tube: K3 EDTA Plasma)

Time frame:Period 1: Visit 2a (Day 1) versus at Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose during each period detected by blood at the begin of the visits and measured by a laboratory (tube: lithium heparin plasma)

Time frame:Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Area under the paracetamol concentration curve to calculate gastric emptying during the Mixed Meal Tolerance Test

Time frame:Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)

AUC₀–∞

concentration, descriptive

Other/protocol endpoint

Number of treatment emergent adverse events

Time frame:From begin of the trial (Day 1) until the end of the trial (Day 204)

Treatment-emergent AEs (any)

event count, event

Other/protocol endpoint

Number of self-reported hypoglycaemic episodes during each period

Time frame:Day 1 until Day 86 (Period 1) compared with Day 113 until day 198 (Period 2)

Documented hypoglycemia

event count, event

Other (unclassified)

7 endpoints
Secondary/protocol endpoint/low confidence

Change in mean plasma glucagon concentrations from begin of the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase

Time frame:After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in mean values of adrenaline from begin of the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase

Time frame:After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in mean values of noradrenaline from begin the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase

Time frame:After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in mean values of cortisol from begin the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase

Time frame:After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in mean values of growth hormone from begin the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase

Time frame:After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in number of regulatory T-cells detected by blood (fasting) and measured by a laboratory

Time frame:After 12 weeks and 2 days of treatment just before the hypoglycaemic clamp in each treatment period (day 86 and day 198)

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in function of regulatory T-cells detected by blood (fasting) and measured by a laboratory

Time frame:After 12 weeks and 2 days of treatment just before the hypoglycaemic clamp in each treatment period (day 86 and day 198)

change from baseline, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.