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OpenTrials
Completed

NCT Number: NCT00572052

Comparison of Glycemic Control Achieved With 2 Different Needles

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate if a 31 gauge x 6 mm needle will provide comparable blood glucose control to the 29 gauge x 12.7 mm needle in obese subjects with diabetes.

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Key information

Conditions

Diabetes Autoimmune Diseases Delivery Systems Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Walnut Creek, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diabetes mellitus
  • Current treatment with insulin or insulin analogues for the last 6 months
  • BMI greater than or equal to 30.0 kg/m2
  • Currently injecting in the thigh or abdomen
  • HbA1c below 10%

Exclusion criteria

  • Severe, uncontrolled hypertension
  • Self-mixing insulin
  • Unwillingness to monitor blood glucose
  • Pregnancy, breast-feeding, intention to become pregnant, or inadequate contraceptive measures

Treatment and study plan

NovoFine® needle 6 mm

Device

Ultra-Fine needle 12.7 mm

Device

Primary outcomes

  1. HbA1c

    Time frame: after 12 weeks of treatment

Secondary outcomes

  1. Subject preference and handling

  2. Frequency of hypoglycaemic episodes

  3. Quality of Life

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Comparison of Glycemic Control Achieved With a 31 Gauge x 6 mm NovoFine® Needle vs. a BD 29 Gauge x 12.7 mm Ultra-Fine® Needle in Subjects With Diabetes Mellitus and a BMI Exceeding 30 kg/m2: An Open Label, Randomized, Two-Period Crossover Study

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Dec 12, 2007
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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