Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT02500979Other idD5570C00002

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 34 participants (actual)
Sponsor: AstraZeneca · Industry
Design: Randomized · Single masking
Countries: 1 country
United States
Start: 17 Aug 2015
Primary completion: 5 Aug 2016
Completion: 5 Aug 2016
First posted: 17 Jul 2015 (estimated)
Last update posted: 2 Nov 2018
Conditions: Type 1 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201520162017

Ph 1
Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus
NCT02500979
17 Aug 2015 to 5 Aug 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Pramlintide acetateDrug
PlaceboDrug
Lispro insulin U-100Drug
Regular insulin U-100Drug

Arms2

Experimental
Pramlintide acetate & regular insulin
Pramlintide will be adiministered by sc infusion at a concentration of 1000ug/mL
Placebo comparator
Placebo and regular insulin
Placebo is similar sterile solution without pramlintide.

Primary outcomes1

Outcomes the sponsor listed as primary.

Efficacy of Pramlintide by Measurement of 24-hour Tissue Mean Weighted Glucose (MWG) Obtained With Continuous Glucose Monitoring (CGM)
Time frame · 24 h
Registry description
24-hour MWG mg/dL, defined as total area under the 24-hour tissue glucose curve obtained with CGM, divided by actual time span in the 24-hour period.

Secondary outcomes(14)

Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Lunch
Time frame · 3 hours
Registry description
Absolute postprandial plasma glucose AUC was measured for the first 3 hours (AUC0-3h) following lunch based on sample availability. (Sample times: 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).
Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Dinner
Time frame · 2 hours
Registry description
Absolute postprandial plasma glucose AUC (AUC0-2h) was measured for the first 2 hours following dinner based on sample availability. (Sample times: 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours).
Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Breakfast
Time frame · 2 hours
Registry description
Absolute postprandial plasma glucose AUC (AUC0-2h) was measured for the first 2 hours following breakfast based on sample availability. (Sample times: 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours).
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
Registry description
Incremental (i.e., baseline-corrected) area under the 24-hour tissue glucose concentration curve (AUC0-24h) measured by continuous glucose monitoring (CGM) with a pre-test, non-fasting tissue glucose value as baseline. (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).
Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC)
Time frame · 24 h
Registry description
Absolute mean area under the 24-hour plasma glucose concentration curve, measured as total area under the curve (0 to 24 hours). (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).
Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC)
Time frame · 24 hours
Registry description
Incremental (i.e., baseline-corrected) mean area under the 24-hour plasma glucose concentration curve, measured as total area under the curve (0 to 24 hours). (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).
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
Registry description
Percent time spent in the normoglycemic range of tissue glucose concentrations between \>70 mg/dL and \<180 mg/dL, measured by CGM. (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).
Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC)
Time frame · 24 h
Registry description
Absolute mean area under the 24-hour plasma glucagon concentration curve, measured as total area under the curve (total AUC0-24). (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).
Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC)
Time frame · 24 h
Registry description
Incremental (i.e., baseline-corrected) mean area under the 24-hour plasma glucagon concentration curve with a pre-test, non-fasting plasma glucagon value as baseline. (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).
Fasting Plasma Glucose Concentration
Time frame · 12 hours after dinner meal
Registry description
Fasting plasma glucose concentration at 0600 hours (6:00 AM)
Pharmacokinetics of Insulin as Demonstrated by 24-hour Plasma Insulin Area Under the Plasma Concentration-time Curve (AUC)
Time frame · 24 hours
Registry description
Mean areas under the plasma insulin concentration curves for the 24-hour periods of pramlintide and placebo administration (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours \[dinner\], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours \[breakfast\], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours \[lunch\], 24 hours).
Pharmacokinetics of Insulin as Demonstrated by 24-hour Average Plasma Insulin Concentration.
Time frame · 24 hours
Registry description
Mean values of the average plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours \[dinner\], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours \[breakfast\], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours \[lunch\], 24 hours).
Pharmacokinetics of Insulin as Demonstrated by Maximum Plasma Insulin Concentration
Time frame · 24 hours
Registry description
Mean maximum plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours \[dinner\], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours \[breakfast\], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours \[lunch\], 24 hours).
Pharmacokinetics of Insulin as Demonstrated by the Time to the Maximum Plasma Insulin Concentration
Time frame · 24 hours
Registry description
Mean time to maximum plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours \[dinner\], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours \[breakfast\], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours \[lunch\], 24 hours).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· 24 h

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

Group	Value (mg/dL)	Spread
Placebo & Regular Insulin	173.8	8.17
Pramlintide & Regular Insulin	152.2	8.17

Secondary and other outcome results(7)

Secondary outcomeLeast squares mean· 3 hours

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

Group	Value (mmol/L*h)
Placebo & Regular Insulin	36.233
Pramlintide & Regular Insulin	28.336

Secondary outcomeLeast squares mean· 2 hours

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

Group	Value (mmol/L*h)
Placebo & Regular Insulin	23.247
Pramlintide & Regular Insulin	17.970

Secondary outcomeLeast squares mean· 2 hours

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

Group	Value (mmol/L*h)
Placebo & Regular Insulin	23.535
Pramlintide & Regular Insulin	19.101

Secondary outcomeLeast squares mean· 24 h

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)

Group	Value (mg/dL*min)	Spread
Placebo & Regular Insulin	26243	3379.8
Pramlintide & Regular Insulin	-2489	3379.8

Secondary outcomeLeast squares mean· 24 h

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

Group	Value (mmol/L*h)
Placebo & Regular Insulin	243.835
Pramlintide & Regular Insulin	215.417

Secondary outcomeMean· 24 hours

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

Group	Value (mmol/L*h)	Spread
Placebo & Regular Insulin	11.181	67.6648
Pramlintide & Regular Insulin	-12.753	70.0174

Secondary outcomeLeast squares mean· 24 h

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)

Group	Value (Percentage of time)
Placebo & Regular Insulin	43.8
Pramlintide & Regular Insulin	57.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Placebo & Regular InsulinPlacebo was similar sterile solution without pramlintide	–	0 / 28	9 / 28
Pramlintide & Regular InsulinPramlintide was administered by sc infusion at a concentration of 1000ug/ml	–	0 / 32	22 / 32

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2018

7 results

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.

Riddle et al. 2018Diabetes carecited by 35

PMID 30213882DOI 10.2337/dc18-1091PUB-30213882

Rights unknown7 results

Source link See results (7)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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