GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1Results posted

Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus

A Randomized, Single-Blind, Two-Way Crossover, Placebo-Controlled Phase I Study to Compare the 24-hour Glucose Profile and Safety of Pramlintide and Insulin, Co-Administered in a Fixed-Dose Ratio, Versus Placebo and Insulin in Patients With Type 1 Diabetes Mellitus With Inadequate Glycemic Control

Lead sponsor

AstraZeneca

Asset

Pramlintide

Amylin analog

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 1 diabetes

Key I/E criterion

•BMI ≤30

Primary endpoint

•Efficacy of Pramlintide by Measurement of 24-hour Tissue Mean Weighted Glucose

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 IDNCT02500979

Org study IDD5570C00002

Timeline

Milestones

Study first posted2015-07-17estimated

Study start2015-08-17actual

Primary completion2016-08-05actual

Study completion2016-08-05actual

Last update posted2018-11-02actual

Results first posted2018-11-02actual

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Provision of informed consent prior to any study-specific procedures

•Female and/or male aged between 18 and 70 years

•Must have a prior diagnosis of T1DM

•Body mass index (BMI) <30 kg/m2

•Subjects are not on current treatment with pramlintide (Symlin) and have not received pramlintide during the 6-month period prior to enrollment

•Subjects should be willing to consume all of the components of the standardized meals administered during the study

•Negative serum pregnancy test for female subjects of childbearing potential

•Female subjects of childbearing potential must be 1 year postmenopausal, surgically sterile, or using an acceptable method of contraception for the duration of the study

•Male subjects must be surgically sterile or using an acceptable method of contraception for the duration of the study

Exclusion criteria

•Recurrent severe hypoglycemia requiring assistance within 6 months before screening

•A history of hypoglycemia unawareness

•A confirmed diagnosis of gastroparesis

•Has been treated, is currently being treated, or is expected to require or undergo treatment with the following medications:

•Any oral antihyperglycemic agent or any other injectable antihyperglycemic agent that is not insulin

•Drugs that directly affect GI motility (eg, anticholinergic agents such as atropine)

•Drugs that slow the intestinal absorption of nutrients (eg, α-glucosidase inhibitors

•A history of gastric surgery (such as gastric banding, Roux- and Y bypass)

•Is expected to require or undergo treatment with acetaminophen after enrollment and at any point during the study

•Has experienced diabetic ketoacidosis within the last 24 weeks

•History of hospitalization within the last 6 months for glycemic control (for both hyperglycemia or hypoglycemia)

•Subject has any significant disease or disorder, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate in the study

•Any clinically relevant abnormal findings, which, in the opinion of the investigator, may put the subject at risk because of his/her participation in the study.

•Pregnancy confirmed by a positive pregnancy test, or otherwise verified.

•Breast feeding

•Positive hepatitis C virus antibody (HCV Ab), hepatitis B virus surface antigen (HBsAg), hepatitis B virus core antibody (anti-Hbc), or human immunodeficiency virus 1/2 antibody (HIV-1/2 Ab) at Screening

•History of, or current alcohol or drug abuse

•Has donated blood within 2 months of Visit 1 (Screening) or is planning to donate blood during the study

•Has had a major surgery or a blood transfusion within 2 months before Visit 1 (screening)

•Participation in any clinical study with an investigational drug or new formulation of a marketed drug during the last 1 month prior to Visit 1

Endpoints (15)

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

Safety / tolerability / PK

Glycemic / diabetes

11 endpoints

Primary/protocol endpoint

Efficacy of Pramlintide by Measurement of 24-hour Tissue Mean Weighted Glucose (MWG) Obtained With Continuous Glucose Monitoring (CGM)

Time frame:24 h

descriptive, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Placebo & Regular Insulin	173.8	—
Pramlintide & Regular Insulin	152.2	—

Least squares mean difference-21.595% CI-37.8 – -5.2p0.0118Linear mixed-effects model

Secondary/protocol endpoint

Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Lunch

Time frame:3 hours

Postprandial glucose

concentration, improvement

Posted result

Group	Value (least_squares_mean), mmol/L*h	95% CI
Placebo & Regular Insulin	36.233	31.427 – 41.039
Pramlintide & Regular Insulin	28.336	23.487 – 33.185

LS mean difference (pramlintide-placebo)-7.89795% CI-12.356 – -3.438p0.0013Linear mixed effects model

Secondary/protocol endpoint

Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Dinner

Time frame:2 hours

Postprandial glucose

concentration, improvement

Posted result

Group	Value (least_squares_mean), mmol/L*h	95% CI
Placebo & Regular Insulin	23.247	20.472 – 26.021
Pramlintide & Regular Insulin	17.970	15.231 – 20.709

LS mean difference (pramlintide-placebo)-5.27795% CI-9.175 – -1.378p0.0091Linear mixed effects model

Secondary/protocol endpoint

Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Breakfast

Time frame:2 hours

Postprandial glucose

concentration, improvement

Posted result

Group	Value (least_squares_mean), mmol/L*h	95% CI
Placebo & Regular Insulin	23.535	20.817 – 26.253
Pramlintide & Regular Insulin	19.101	16.280 – 21.922

LS mean difference (pramlintide-placebo)-4.43595% CI-7.445 – -1.424p0.0057Linear mixed effects model

Secondary/protocol endpoint

Efficacy of Pramlintide by Measurement of Incremental 24-hour Tissue Glucose Area Under the Plasma Concentration-time Curve (AUC) Obtained With Continuous Glucose Monitoring (CGM)

Time frame:24 h

descriptive, improvement

Posted result

Group	Value (least_squares_mean), mg/dL*min	95% CI
Placebo & Regular Insulin	26243	—
Pramlintide & Regular Insulin	-2489	—

Least squares mean difference-2873395% CI-37326 – -20139p<0.0001Linear mixed-effects model

Secondary/protocol endpoint

Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC)

Time frame:24 h

concentration, improvement

Posted result

Group	Value (least_squares_mean), mmol/L*h	95% CI
Placebo & Regular Insulin	243.835	220.032 – 267.638
Pramlintide & Regular Insulin	215.417	191.614 – 239.220

LS mean difference-28.41895% CI-53.099 – -3.737p0.0258Linear mixed-effects model

Secondary/protocol endpoint

Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC)

Time frame:24 hours

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L*h	95% CI
Placebo & Regular Insulin	11.181	—
Pramlintide & Regular Insulin	-12.753	—

Secondary/protocol endpoint

Efficacy of Pramlintide Measured by Percent Time Spent in the Range of >70 mg/dL to <180 mg/dL Tissue Glucose Obtained With Continuous Glucose Monitoring (CGM)

Time frame:24 h

CGM time-in-range

descriptive, improvement

Posted result

Group	Value (least_squares_mean), Percentage of time	95% CI
Placebo & Regular Insulin	43.8	33.6 – 56.9
Pramlintide & Regular Insulin	57.2	44.0 – 74.4

LS Mean Ratio (Pramlintide/Placebo)1.3195% CI1.01 – 1.70p0.0456Linear mixed-effects model

Secondary/protocol endpoint

Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC)

Time frame:24 h

plasma glucagon auc 24h

concentration, improvement

Posted result

Group	Value (least_squares_mean), h*pmol/L	95% CI
Placebo & Regular Insulin	506.265	459.096 – 558.280
Pramlintide & Regular Insulin	481.633	436.759 – 531.118

LS mean ratio (pramlintide/placebo)0.95195% CI0.896 – 1.011p0.1015Linear mixed-effects model

Secondary/protocol endpoint

Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC)

Time frame:24 h

concentration, descriptive

Posted result

Group	Value (mean), pmol/L*h	95% CI
Placebo & Regular Insulin	-14.954	—
Pramlintide & Regular Insulin	-16.055	—

Secondary/protocol endpoint

Fasting Plasma Glucose Concentration

Time frame:12 hours after dinner meal

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Placebo & Regular Insulin	7.794	6.631 – 9.162
Pramlintide & Regular Insulin	8.459	7.196 – 9.943

LS mean ratio (pramlintide/placebo)1.08595% CI0.901 – 1.307p0.3730Linear mixed effects model

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Pharmacokinetics of Insulin as Demonstrated by 24-hour Plasma Insulin Area Under the Plasma Concentration-time Curve (AUC)

Time frame:24 hours

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (mean), mU/L*h	95% CI
Placebo & Regular Insulin	380.525	—
Pramlintide & Regular Insulin	377.324	—

Secondary/protocol endpoint

Pharmacokinetics of Insulin as Demonstrated by 24-hour Average Plasma Insulin Concentration.

Time frame:24 hours

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Value (mean), mIU/L	95% CI
Placebo & Regular Insulin	15.855	—
Pramlintide & Regular Insulin	15.722	—

Secondary/protocol endpoint

Pharmacokinetics of Insulin as Demonstrated by Maximum Plasma Insulin Concentration

Time frame:24 hours

Cmax

concentration, descriptive

Posted result

Group	Value (mean), mIU/L	95% CI
Placebo & Regular Insulin	33.144	—
Pramlintide & Regular Insulin	32.838	—

Secondary/protocol endpoint

Pharmacokinetics of Insulin as Demonstrated by the Time to the Maximum Plasma Insulin Concentration

Time frame:24 hours

Tmax

concentration, descriptive

Posted result

Group	Value (mean), h	95% CI
Placebo & Regular Insulin	10.556	—
Pramlintide & Regular Insulin	11.653	—

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

Control of Postprandial Hyperglycemia in Type 1 Diabetes by 24-Hour Fixed-Dose Coadministration of Pramlintide and Regular Human Insulin: A Randomized, Two-Way Crossover Study.
Diabetes care2018 Nov (month)PMID30213882doi:10.2337/dc18-1091via 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.