CompletedPhase 3

Local Registration Trial in China Humalog Mix 50

China120 participantsStarted 2005-03

Plain-language summary

The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in insulin-requiring diabetic patients treated twice daily with human insulin mix 50/50, versus the 2-hour PPBG excursion in patients treated twice daily with insulin lispro mix 50/50.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Men and women who have had either type 1 or type 2 diabetes (World Health Organization\[WHO\]classification)for at least 2 months and are between the ages of 18 and 70 (inclusive) at the signing of the informed consent.
✓. Have been treated with commercially available human insulin mix 50/50 or human insulin mix 30/70 twice daily as the only pharmacological treatment for their diabetes for at least 2 months prior to entering the study.
✓. Have an HbA1c between 1.1 and 1.7 times the upper limit of the normal reference rang(inclusive) as determined by a local laboratory within 2 weeks prior to or at Visit 1.
✓. Have achieved compliance with their diets and insulin therapies as determined by the investigators and perform regular blood glucose monitoring.
✓. Have given informed consent to participate in this study in accordance with local regulations.

What they're measuring

The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in IDDM patients treated BID with human insulin mix 50/50, vs the 2-hour PPBG excursion in patients treated BID with insulin lispro mix 50/50

Trial details

NCT IDNCT00191581

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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