Type 2 Diabetes and treated with NPH or basal insulin

  • STATUS
    Recruiting
  • sponsor
    Novo Nordisk
Updated on 8 November 2020

Summary

Type 2 Diabetes and treated with NPH or basal insulin

Description

A 15 month clinical research study is evaluating if a new investigational basal insulin dosed once daily can provide safe and effective blood sugar control compared to a marketed basal insulin dosed once daily in people with type 2 diabetes.

Qualified participants will receive all study-related care and study medication at no cost and may be compensated for travel.

Details
Condition Diabetes Mellitus, Type 2
Clinical Study IdentifierTX138188
SponsorNovo Nordisk
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Are 18 years or older
Have had a diagnosis of type 2 diabetes for at least 6 months
Are receiving treatment with any basal insulin with or without oral anti-diabetic drugs for at least 6 months
Are at high risk for developing hypoglycaemia (ie. recent hypoglycaemic episode, severe hypoglycaemic episode, hypoglycaemic unawareness, moderate chronic renal failure or insulin usage for more than 5 years)
Have an HbA1c level of not more than 9.5%; and
Have a body mass index (BMI) of less than 45kg/m
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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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