GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1Results posted

Evaluation of the Glucoregulatory Effects of Glucagon-like Peptide-1 Receptor (GLP-1 Receptor) Activation in Participants With Type 2 Diabetes Mellitus (MK-0000-222)

Evaluation of the Glucoregulatory Effects of GLP-1 Receptor Activation in Patients With Type 2 Diabetes Mellitus

Lead sponsor

Merck Sharp & Dohme LLC

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤38•HbA1c ≤9%•Male

Primary endpoints

•Postprandial glucose•Beta Cell Sensitivity to Glucose (Φ) After a Single Dose of OXM•Maximum Ambient Glucose Concentration (Gmax) After a Single Dose of OXM

Identifiers

Registered as

NCT IDNCT01373450

Org study ID0000-222

Timeline

Milestones

Study first posted2011-06-15estimated

Results first posted2013-07-08estimated

Last update posted2015-09-02estimated

Study start2011-06 (month precision)

Primary completion2011-07actual (month precision)

Study completion2011-07actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexMale

Healthy volunteersNot accepted

Inclusion criteria

•Have a body mass index (BMI) of ≤38.0 kg/m^2

•Have a clinical diagnosis of Type 2 diabetes mellitus

•Have a glycated hemoglobin (HbA1C) at screening ≤9.0%; fasting plasma glucose should not exceed 300 mg/dL (16.8 mmol/L)

•Judged to be in good health

Exclusion criteria

•Have a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study

•Have a history of stroke, chronic seizures, major neurological disorder, clinically significant endocrine, cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases

•Have untreated hypertension with blood pressure of >160/95 mmHg

•Have a history of neoplastic disease within the past 5 years

•Have a history of hypersensitivity to OXM, liraglutide, insulin or Haemaccel®

•Unable or unwilling to comply with restrictions around concomitant medications

•Consume excessive amounts of alcohol, coffee, tea, cola, or other caffeinated beverages daily

•Have had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks

•Have a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food

•Currently a regular user (including use of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months

•Are unwilling or unable to consume the standardized meals during the study and/or is on a carbohydrate restricted diet (i.e., a diet <100 grams per day of carbohydrate)

Endpoints (12)

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.

Glycemic / diabetes

12 endpoints

Primary/registry result

Change From Baseline in Time-weighted Average of Glucose Measured by Area Under the Curve (AUC) After a Single Dose of Oxyntomodulin (OXM)

Time frame:Baseline and during GGI at time points 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 minutes

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Oxyntomodulin	106.3	—
Placebo	122.6	—

Geometric Mean Ratio0.8790% CI0.77 – 0.98p0.024t-test, 1 sided

Primary/registry result

Change From Baseline in Maximum Ambient Glucose Concentration (Gmax) After a Single Dose of OXM

Time frame:Baseline and up to 160 minutes after start of GGI

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Oxyntomodulin	211.0	—
Placebo	272.9	—

Geometric Mean Ratio0.7790% CI0.66 – 0.90p0.004t-test, 1 sided

Primary/registry result/low confidence

Change From Baseline in Beta Cell Sensitivity to Glucose (Φ) After a Single Dose of OXM

Time frame:Baseline and up to160 minutes after start of GGI

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), ISR (ng/mL) / Glucose (mg/dL)	95% CI
Oxyntomodulin	0.019	—
Placebo	0.006	—

Least Square Mean Difference0.01490% CI0.008 – 0.019p<0.001t-test, 1 sided

Primary/protocol endpoint

Change From Baseline in Time-weighted Average of Glucose Measured by Area Under the Curve (AUC) After a Single Dose of Oxyntomodulin (OXM)

Time frame:Baseline and during GGI at time points 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 minutes

Postprandial glucose

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline in Maximum Ambient Glucose Concentration (Gmax) After a Single Dose of OXM

Time frame:Baseline and up to 160 minutes after start of GGI

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline in Beta Cell Sensitivity to Glucose (Φ) After a Single Dose of OXM

Time frame:Baseline and up to160 minutes after start of GGI

change from baseline, improvement

Secondary/registry result/low confidence

Change From Baseline in Insulinotrophic Effect (ISR/G) at the Highest Glucose Infusion Rate After Two Periods of Placebo Treatment

Time frame:Baseline and 160 minutes after start of GGI at each placebo treatment period

change from baseline, improvement

Posted result

Group	Value (mean), ISR (ng/mg) / Glucose (mg/dL)	95% CI
Placebo Period 1	0.0075	—
Placebo Period 2	0.0070	—

Intraclass Correlation Coefficient0.9290% CI0.72 – 0.98

Secondary/registry result

Change From Baseline in Gmax After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM

Time frame:Baseline and up to 160 minutes after start of GGI

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Liraglutide 0.6 mg	209.7	—
Liraglutide 1.2 mg	157.9	—
Oxyntomodulin	211.0	—
Placebo	272.9	—

Geometric Mean Ratio0.7790% CI0.66 – 0.90p0.003t-test, 1 sided

Geometric Mean Ratio0.5890% CI0.45 – 0.74p<0.001t-test, 1 sided

Geometric Mean Ratio0.9990% CI0.85 – 1.16p0.473t-test, 1 sided

Geometric Mean Ratio0.7590% CI0.56 – 1.00p0.049t-test, 1 sided

Secondary/registry result/low confidence

Change From Baseline in Insulinotrophic Effect (ISR/G) After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM

Time frame:Baseline and up to 160 minutes after start of GGI

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), ISR (ng/min) / Glucose (mg/dL)	95% CI
Liraglutide 0.6 mg	0.026	—
Liraglutide 1.2 mg	0.035	—
Oxyntomodulin	0.019	—
Placebo	0.006	—

Least Square Mean Difference0.02190% CI0.015 – 0.026p<0.001t-test, 1 sided

Least Square Mean Difference0.03090% CI0.021 – 0.038p<0.001t-test, 1 sided

Least Square Mean Difference0.00790% CI0.002 – 0.012p0.0163t-test, 1 sided

Least Square Mean Difference0.01690% CI0.006 – 0.026p0.0056t-test, 1 sided

Secondary/protocol endpoint

Change From Baseline in Insulinotrophic Effect (ISR/G) at the Highest Glucose Infusion Rate After Two Periods of Placebo Treatment

Time frame:Baseline and 160 minutes after start of GGI at each placebo treatment period

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Gmax After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM

Time frame:Baseline and up to 160 minutes after start of GGI

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Insulinotrophic Effect (ISR/G) After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM

Time frame:Baseline and up to 160 minutes after start of GGI

change from baseline, improvement

Publications (2)

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

Native Oxyntomodulin Has Significant Glucoregulatory Effects Independent of Weight Loss in Obese Humans With and Without Type 2 Diabetes.
Diabetes2018 Jun (month)PMID29545266doi:10.2337/db17-1331via clinicaltrials gov reference derived + pubmed nct search
Linearity of β-cell response across the metabolic spectrum and to pharmacology: insights from a graded glucose infusion-based investigation series.
American journal of physiology. Endocrinology and metabolism2016 Jun 1PMID27072496doi:10.1152/ajpendo.00527.2015via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.