GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Study to Evaluate the Effect of Ranolazine on Postprandial Glucagon in Subjects With Type 2 Diabetes.

A Phase 1, Randomized, Single-blind, Placebo-controlled, Multiple-dose, Two-sequence, Cross-over Study to Evaluate the Effect of Ranolazine on Glucagon Secretion in Subjects With Type 2 Diabetes Mellitus, Followed by An Open-label, Single Dose, Exenatide Active-control Period

Lead sponsor

Gilead Sciences

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 20-40•HbA1c 7-10.5%•eGFR ≥60

Primary endpoint

•AUC of plasma glucagon during the standard meal test (SMT)

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 IDNCT01843127

Org study IDGS-US-259-0165

Timeline

Milestones

Study first posted2013-04-30estimated

Last update posted2014-03-31estimated

Study start2013-04 (month precision)

Primary completion2013-09actual (month precision)

Study completion2013-09actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Males and females, 18 to 65 years old, inclusive

•Documented history of T2DM for ≥5 years

•Body mass index (BMI) 20.0 to 40.0 kg/m2, inclusive, at Screening

•Stable treatment (≥ 12 weeks) with metformin alone, a sulfonylurea alone, a meglitinide alone, or a combination of metformin with either a sulfonylurea or a meglitinide

•HbA1c ≥ 7.0% and ≤ 10.5%, inclusive, at Screening

•Fasting glucose within specific ranges, at Screening and after 14 +/-2 days of wash-out from prior oral anti-diabetic agents

•Fasting serum C-peptide ≥0.8 ng/mL, at Screening

•Estimated glomerular filtration rate (eGFR)≥60 mL/min/1.73 m2

•Ability and willingness to comply with all study procedures during the course of the study, including washout from oral anti-diabetic (OAD) agents approximately 2 weeks prior to Day -2 admission

•Females of childbearing potential must have a negative pregnancy test at Screening and on Day -2 admission and must agree to use highly effective contraception methods from Screening throughout study participation and for 14 days following the last dose of study drug.

Exclusion criteria

•History of type 1 diabetes mellitus or secondary forms of diabetes

•History of acute diabetes complications

•Recent or significant heart conditions

•Uncontrolled hypertension

•QTc interval > 500 msec by ECG at Screening or on Day -2 admission, a personal or family history of QTc prolongation, congenital long QT syndrome, or use of drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)

•History of severe GI disease (e.g., gastroparesis)

•History of pancreatitis (acute or chronic)

•Current consumption of > 14 alcoholic drinks per week, or more than 4 alcoholic drinks on any one day

•Current regular use of tobacco- or nicotine-containing products in excess of 10 cigarettes per day or equivalent

•History of substance abuse within 12 months prior to Screening

•Significant hepatic disease, including, but not limited to, chronic active hepatitis and liver cirrhosis (Child-Pugh Class A, B, or C)

•History of malignancy within 5 years prior to Screening

•Significant thyroid disease

•Treatment with selected medications, as indicated in the protocol

•Prior treatment with open-label ranolazine or known hypersensitivity or intolerance to ranolazine or its excipients

•Known hypersensitivity or intolerance to GLP-1 mimetics

•Known hypersensitivity or intolerance to acetaminophen

•Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 X upper limit of normal (ULN)

•Total Bilirubin (TB) > 2 mg/dL

•Hemoglobin < 12 g/dL (for males) or < 11 g/dL (for females)

•Positive for hepatitis B surface antigen

•Positive for anti-hepatitis C virus antibody

•Positive for human immunodeficiency virus-1 (HIV-1) antibody

•Positive urine drug screen

•Positive alcohol test

•Donation of blood or blood products to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of > 500 mL of blood during the 6 weeks prior to Screening

•Females who are pregnant or breastfeeding

•Other condition(s) that, in the opinion of the investigator, would compromise the safety of the subject, would prevent compliance with the study protocol, or would compromise the quality of the clinical study.

Endpoints (10)

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

Safety / tolerability / PK

Glycemic / diabetes

Other (unclassified)

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint/low confidence

Plasma glucose, serum insulin, and serum C-peptide AUCs during the SMT

Time frame:Days 5, 10, and 14

descriptive

componentsPostprandial glucose, C-peptide AUC

Safety / tolerability / PK

8 endpoints

Secondary/protocol endpoint/low confidence

Collapse under Acetaminophen PK

Time frame:Days 5 and 10

descriptive

Secondary/protocol endpoint

Area under the plasma acetaminophen concentration-time curve from time 0 to 240 min (AUC0-240 min)

Time frame:Days 5 and 10

concentration, descriptive

Secondary/protocol endpoint

Collapse all under ranolazine pharmacokinetics (PK)

Time frame:Days 5 and 10

descriptive

Secondary/protocol endpoint

Trough plasma ranolazine concentrations (Ctrough)

Time frame:Days 5 and 10

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Average plasma ranolazine concentration during a dosing interval at steady state (Css,ave)

Time frame:Days 5 and 10

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Area under the plasma ranolazine concentration-time curve over dosing interval (AUCtau)

Time frame:Days 5 and 10

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Apparent elimination half-life (t1/2) of ranolazine

Time frame:Days 5 and 10

Half-life

descriptive

Secondary/protocol endpoint

Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.

Time frame:From Screening to 7 days after the final dose

descriptive

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Area under the concentration-time curve (AUC) of plasma glucagon during the standard meal test (SMT)

Time frame:Days 5, 10, and 14

concentration, descriptive

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.