Comparison of Premixed Insulins Aspart 30, Aspart 70 and Aspart on Postprandial Lipids

NCT01293396 | Completed Phase 4 Results

• 2 other identifiers: ENM-DA-0082008-008486-35
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate meal-related treatment with either premixed Insulin Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free fatty acids excursions after a standard breakfast and lunch.

Conditions

Type 2 Diabetes

Keywords

insulin aspart 30; insulin aspart 70; insulin aspart; postprandial glucose and lipid metabolism; consecutive mixed meals

Outcome Measures

Primary Outcomes (2)

• Area Over Basal for Postprandial Glucose From 0 to 600min

  Area over basal for postprandial glucose from 0 (Fasting glucose, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.

  0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)

• Area Over Basal for Postprandial Triglycerides

  Area over basal for postprandial triglycerides from 0 (Fasting triglycerides, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.

  0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)

Secondary Outcomes (4)

• Maximum Glucose Increase

  0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)

• Maximum Triglyceride Increase

  0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)

• Area Over Basal for Postprandial Insulin

  0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)

• Area Over Basal for Postprandial C-peptide

  0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)

Study Arms (3)

Biphasic Insulin Aspart 30

ACTIVE COMPARATOR

35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch

Drug: Insulin Aspart 30

Biphasic Insulin Aspart 70

ACTIVE COMPARATOR

35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch

Drug: Insulin Aspart 70

Insulin Aspart

ACTIVE COMPARATOR

35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch

Drug: Insulin Aspart

Interventions

Insulin Aspart DRUG

Patients received insulin aspart before breakfast and before lunch.

Also known as: Novorapid

Insulin Aspart

Insulin Aspart 30 DRUG

Patients received biphasic insulin aspart 30 before breakfast and before lunch.

Also known as: Novomix 30

Biphasic Insulin Aspart 30

Insulin Aspart 70 DRUG

Patients received biphasic insulin aspart 70 before breakfast and before lunch.

Also known as: Novomix 70

Biphasic Insulin Aspart 70

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type-II Diabetes
• BMI \> 27 kg/m2
• age 35 to 75 years
• HbA1c \< 8.5%
• informed consent
• treatment with pre-mixed insulin
• stabile dose of insulin for at least 4 weeks

You may not qualify if:

• Type-I Diabetes mellitus
• HbA1c \> 8.5 %
• Serum Creatinine \> 1.7 mg/dl
• Alaninaminotranferase or Aspartataminotransferase \> 3x Upper Limit of Normal
• treatment with sulfonylurea or gliptins
• treatment with glitazones
• manifest clinical infections
• treatment with glucocorticoids or antipsychotic drugs
• psychiatric diseases
• alcohol abuse
• myocardial infarction or stroke within the previous 3 months
• surgery within the previous 3 months

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz, Department for Internal Medicine

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Aspart; insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Norbert Tripolt
• Organization: Medical University of Graz

norbert.tripolt@medunigraz.at

0316385

Study Officials

• Harald Sourij, MD

  Medical University of Graz, 8036 Graz, Austria

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 10, 2011
• Study Start: June 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 30, 2021
• Results First Posted: June 30, 2021

Record last verified: 2021-06

Locations

AU (1)