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

Comparison of the Impact of Biphasic Insulin Aspart 30 (BiAsp 30), Biphasic Insulin Aspart 70 (BiAsp 70) and Insulin Aspart on Postprandial Glucose and Lipid Metabolism During Two Consecutive Meals in Type 2 Diabetics.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01293396

Acronym

HUCKEPACK2

Enrollment

Registered

2011-02-10

Start date

2010-06-30

Completion date

2011-03-31

Last updated

2021-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

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

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.

Detailed description

Whereas the effects of each of the established types of insulin (remixed Insulin Aspart 30, Aspart 70 and Aspart) have been shown before, their specific glucose and lipid lowering capacities have so far not been investigated in a simulated physiological situation.

Interventions

DRUGInsulin Aspart

Patients received insulin aspart before breakfast and before lunch.

DRUGInsulin Aspart 30

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

DRUGInsulin Aspart 70

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Area Over Basal for Postprandial Glucose From 0 to 600min	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 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.
Area Over Basal for Postprandial Triglycerides	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 from 0 (Fasting triglycerides, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.

Secondary

Measure	Time frame	Description
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 glucose increase from baseline to 600min after baseline
Maximum Triglyceride Increase	0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)	Maximum trigylceride increase from Baseline to 600min after Baseline
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 insulin from 0 (Fasting insulin, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
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)	Area over basal for postprandial c-peptide from 0 (Fasting c-peptide, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.

Countries

Austria

Participant flow

Recruitment details

50 patients were screened and in total 20 randomizations were performed. After randomization 20 randomized subjects finished all three study visits.

Pre-assignment details

All subjects received all of the three insulins within various sequences in a randomized order. Randomisation lists for the insulin sequence were provided by a researcher otherwise not involved in the clinical trial performance.

Participants by arm

Arm	Count
Overall Study 20 patients with type 2 diabetes receive insulin aspart, premixed biphasic insulin 30 and premixed biphasic insulin aspart 70 in randomized order.	20
Total	20

Baseline characteristics

Characteristic	Overall Study
Age, Continuous	65 years STANDARD_DEVIATION 6
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	20 Participants
Sex: Female, Male Female	6 Participants
Sex: Female, Male Male	14 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 20	0 / 20	0 / 20
other Total, other adverse events	1 / 20	2 / 20	2 / 20
serious Total, serious adverse events	0 / 20	0 / 20	0 / 20

Outcome results

Primary

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.