A Study to Assess Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus

NCT02419859 | Completed

• 1 other identifier: CQR14002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2 diabetes mellitus (T2DM).

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin; Continuous subcutaneous insulin infusion (CSII); Insulin pumps

Outcome Measures

Primary Outcomes (1)

• Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)

  Change from Baseline at 12 weeks

Secondary Outcomes (10)

• Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)

  Change from Baseline at 8 weeks

• Fasting plasma glucose

  Change from Baseline at 12 weeks

• 7-point blood glucose profiles

  Change from Baseline at 12 weeks

• Total daily dose of insulin

  Change from Baseline at 12 weeks

• Body weight

  Change from Baseline at 12 weeks

Study Arms (1)

PaQ® Insulin Delivery Device

EXPERIMENTAL

The intervention is continuous subcutaneous U 100 Insulin, Asp(B28)-rapid-acting insulin, at a constant basal rate of either 20, 24, 32, 40 or 50 U per day over 3 days and and bolus insulin as needed at meals in 2 U increments.

Device: PaQ® Insulin Delivery Device; Drug: Insulin, Asp(B28)-

Interventions

PaQ® Insulin Delivery Device DEVICE

PaQ is a 3 day insulin delivery device which delivers U 100 rapid-acting insulin. Provides basal insulin at preset basal doses and bolus insulin (in 2 unit increments) with a push of a button.

PaQ® Insulin Delivery Device

Insulin, Asp(B28)- DRUG

a fast-acting analog of human insulin

Also known as: NovoRapid

PaQ® Insulin Delivery Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is at least 18 years of age;
• Has a clinical diagnosis of T2DM, as determined by clinical history and medication usage;
• Has an A1C ≥ 7.0% and ≤ 11.0%;
• Is treated with basal-bolus insulin therapy (at least 2 injections per day) with or without OADs, and/or GLP-1 agonist for at least 3 months and has not had a change (addition or discontinuation of existing drug or change in dose) in their OADs for the last 8 weeks, (See Section 7.4 for definition of baseline basal bolus therapy);
• Determined by the investigator that insulin requirements to achieve glycemic targets can be met by the insulin capacity of the PaQ device;
• If on concomitant metformin, has serum creatinine \<1.5 mg/dL (male) or \<1.4 mg/dL (female);
• If female, and of child-bearing potential, has a negative urine pregnancy test at screening and must be using adequate means of contraception as determined by the Investigator;
• Is clinically euthyroid as judged by the Investigator;
• Is able to understand and sign the required study documents and comply with the CIP requirements;
• Is deemed capable by the Investigator to perform the requirements of the CIP, including use of PaQ, frequent self-monitoring of blood glucose.

You may not qualify if:

• Is poorly compliant with the currently prescribed diabetes regimen, as determined by the Investigator;
• Is poorly compliant with prescribed self-monitoring of blood glucose, as determined by the Investigator;
• Is currently taking or has taken sulfonylureas within the last 2 months;
• Has a BMI greater than 40 kg/m2;
• Has experienced recurrent severe hypoglycemia (\> 2 episodes) requiring assistance during the past 6 months;
• Has existing dermal irritation/inflammation over the abdominal area that may interfere with use of PaQ, as determined by the Investigator;
• Has known clinically significant hypersensitivity to skin adhesives;
• Is female and if of child-bearing potential, is pregnant, lactating, or planning to become pregnant;
• Is currently being treated with or expected to require or undergo treatment with systemic steroids by oral, intravenous, or intramuscular route (inhaled with low systemic exposure is permitted);
• Currently abuses drugs or alcohol or has a history of abuse that in the Investigator's opinion would cause the individual to be non-compliant;
• Has received any investigational drug within 1 month;
• Has donated blood within 30 days;
• Has any significant medical condition (including current or past history of cardiovascular disease), laboratory findings, or medical history that in the Investigator's opinion may affect successful completion of the study and/or personal well-being;
• Is an immediate family member (spouse, parent, child, or sibling) of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site.

Sponsors & Collaborators

• CeQur Corporation: lead

Study Sites (1)

Medical University of Graz

Graz, A-8036, Austria

Location

Related Publications (1)

• Mader JK, Lilly LC, Aberer F, Poettler T, Johns D, Trautmann M, Warner JL, Pieber TR. Improved glycaemic control and treatment satisfaction with a simple wearable 3-day insulin delivery device among people with Type 2 diabetes. Diabet Med. 2018 Oct;35(10):1448-1456. doi: 10.1111/dme.13708. Epub 2018 Jul 5.

  PMID: 29888811 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Thomas Pieber, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: April 17, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 26, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)