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Trial · Interventional

CompletedPhase 3Registry data

Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.

NCTNCT00313001 (opens ClinicalTrials.gov in a new tab)Other idBIASP-1714
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
373 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Apr 2006
Primary completion
Jul 2007
Completion
Jul 2007
First posted
11 Apr 2006 (estimated)
Last update posted
6 Jan 2017 (estimated)
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008
  1. Ph 3

    Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.

    NCT00313001

    Apr 2006 to Jul 2007

Registry summary

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

This trial is conducted in the United States of America (USA). The study will compare A1C reduction achieved in patients receiving biphasic insulin aspart 70/30 once or twice daily to patients receiving exenatide twice daily. Patients enrolled in the study will be insulin naive patients who have not achieved glycemic control with metformin and sulfonylurea.

Interventions

  • biphasic insulin aspartDrug
  • exenatideDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Superiority as assessed by HbA1c reduction

    Time frame · at 24 weeks

Secondary outcomes(2)

  1. Safety variables

  2. Patient satisfaction

Posted results

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

No results are posted for this trial.

Completed trials do not always post results.

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 · 2009

9 results

Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 diabetes failing to achieve glycemic control with metformin and a sulfonylurea.

Bergenstal et al. 2009Current medical research and opinioncited by 68

PMID 19210140DOI 10.1185/03007990802597951PUB-19210140

Full text at the publisher9 results
Publisher pageSee results (9)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Type 2 diabetes * HbA1C: At least 8% * Patients that were never treated with insulin before * Current therapy with metformin and a sulfonylurea. Exclusion Criteria: * History of recurrent, severe hypoglycemia * Hepatic insufficiency: ALT, AST or alkaline phosphatase \> 2.5 times upper limits of laboratory's normal * Renal insufficiency: serum creatinine \> 1.3 mg/dL (males) or \> 1.2 mg/dL (females) * Severe gastrointestinal disease, including gastroparesis

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