Phase 1 Completed N=33 Randomized Single-blind Treatment

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

Source: ClinicalTrials.gov NCT02500979 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcomePrimary: Efficacy of Pramlintide by Measurement of 24-hour Tissue Mean Weighted Glucose (MWG) Obtained With Continuous Glucose Monitoring (CGM) — 173.8; 152.2 mg/dL — p=0.0118

Summary

This study is designed to investigate the clinical efficacy and safety of pramlintide co-administered as a fixed-dose ratio with basal-bolus SC insulin, delivered simultaneously via 2 separate pumps, in subjects with type 1 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.

Outcome Measures

Outcome	Result	p-value
PRIMARY Efficacy of Pramlintide by Measurement of 24-hour Tissue Mean Weighted Glucose (MWG) Obtained With Continuous Glucose Monitoring (CGM)	173.8; 152.2	0.0118 sig
SECONDARY Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Lunch	36.233; 28.336	0.0013 sig
SECONDARY Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Dinner	23.247; 17.970	0.0091 sig
SECONDARY Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Breakfast	23.535; 19.101	0.0057 sig
SECONDARY 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)	26243; -2489	<0.0001 sig
SECONDARY Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC)	243.835; 215.417	0.0258 sig
SECONDARY Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC)	11.181; -12.753	—
SECONDARY 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)	43.8; 57.2	0.0456 sig
SECONDARY Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC)	506.265; 481.633	0.1015
SECONDARY Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC)	-14.954; -16.055	—
SECONDARY Fasting Plasma Glucose Concentration	7.794; 8.459	0.3730
SECONDARY Pharmacokinetics of Insulin as Demonstrated by 24-hour Plasma Insulin Area Under the Plasma Concentration-time Curve (AUC)	380.525; 377.324	—
SECONDARY Pharmacokinetics of Insulin as Demonstrated by 24-hour Average Plasma Insulin Concentration.	15.855; 15.722	—
SECONDARY Pharmacokinetics of Insulin as Demonstrated by Maximum Plasma Insulin Concentration	33.144; 32.838	—
SECONDARY Pharmacokinetics of Insulin as Demonstrated by the Time to the Maximum Plasma Insulin Concentration	10.556; 11.653	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02500979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.