NCT00346996

Brief Summary

Severe hypoglycaemia is hampering the lives of many diabetic patients. The effect on the occurrence of severe hypoglycaemia during two different insulin regimens are to be investigated. In total, 250 hypoglycaemia prone type 1 diabetic patients will be randomised to receive analogue and human insulin for one year in random order. Outcomes will be number of episodes of severe hypoglycaemia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

4.5 years

First QC Date

June 30, 2006

Last Update Submit

August 31, 2012

Conditions

Type 1 Diabetes

Keywords

diabetesinsulininsulin analogueshypoglycaemiasevere hypoglycaemia

Outcome Measures

Primary Outcomes (1)

  • Severe hypoglycaemia

    9 months

Secondary Outcomes (3)

  • asymptomatic hypoglycaemia

    9 months

  • hypoglycaemia during nighttime

    9 months

  • hypoglycaemia during daytime

    9 months

Study Arms (2)

1

ACTIVE COMPARATOR

HUman Insulin

Drug: human insulin /insulin isophane

2

EXPERIMENTAL

Analogue insulin

Drug: insulin levemir / aspart

Interventions

insulin levemir / aspartDRUG

for subcutaneous injection

2
human insulin /insulin isophaneDRUG

for subcutaneous injection

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes for 5 years.
  • Age\>18 years.
  • Two or more episodes of hypoglycaemia during the last year,

You may not qualify if:

  • History of Addisons disease
  • Growth hormone deficiency or untreated myxoedema
  • CVD within 6 months
  • Cancer within 5 years
  • Alcohol or drug abuse
  • Pregnant or lactating women
  • Fertile women without effective contraception
  • Participation in another trial within 30 days
  • Inability to understand the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center

Gentofte Municipality, DK-2820, Denmark

Location

Related Publications (4)

  • Pedersen-Bjergaard U, Kristensen PL, Norgaard K, Perrild H, Jensen T, Thorsteinsson B, Nikolajsen A, Tarnow L. Short-term cost-effectiveness of insulin detemir and insulin aspart in people with type 1 diabetes who are prone to recurrent severe hypoglycemia. Curr Med Res Opin. 2016 Oct;32(10):1719-1725. doi: 10.1080/03007995.2016.1205006. Epub 2016 Jul 20.

    PMID: 27326862DERIVED

  • Agesen RM, Kristensen PL, Beck-Nielsen H, Norgaard K, Perrild H, Christiansen JS, Jensen T, Hougaard P, Parving HH, Thorsteinsson B, Tarnow L, Pedersen-Bjergaard U. Effect of insulin analogues on frequency of non-severe hypoglycaemia in patients with type 1 diabetes prone to severe hypoglycaemia: The HypoAna trial. Diabetes Metab. 2016 Sep;42(4):249-55. doi: 10.1016/j.diabet.2016.03.001. Epub 2016 Apr 7.

    PMID: 27068361DERIVED

  • Pedersen-Bjergaard U, Kristensen PL, Beck-Nielsen H, Norgaard K, Perrild H, Christiansen JS, Jensen T, Hougaard P, Parving HH, Thorsteinsson B, Tarnow L. Effect of insulin analogues on risk of severe hypoglycaemia in patients with type 1 diabetes prone to recurrent severe hypoglycaemia (HypoAna trial): a prospective, randomised, open-label, blinded-endpoint crossover trial. Lancet Diabetes Endocrinol. 2014 Jul;2(7):553-61. doi: 10.1016/S2213-8587(14)70073-7. Epub 2014 May 2.

    PMID: 24794703DERIVED

  • Kristensen PL, Pedersen-Bjergaard U, Beck-Nielsen H, Norgaard K, Perrild H, Christiansen JS, Jensen T, Parving HH, Thorsteinsson B, Tarnow L. A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design. BMC Endocr Disord. 2012 Jun 22;12:10. doi: 10.1186/1472-6823-12-10.

    PMID: 22727048DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusInsulin ResistanceHypoglycemia

Interventions

Insulin AspartIsophane Insulin, Human

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, IsophaneInsulin, Long-ActingInsulin, Regular, HumanInsulinProinsulin

Study Officials

  • Lise Tarnow, MD

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

May 1, 2007

Primary Completion

November 1, 2011

Study Completion

August 1, 2012

Last Updated

September 3, 2012

Record last verified: 2012-08

Locations

DK(1)