Trial Outcomes & Findings for Safety of Continuing Metformin in Diabetic Patients With Normal Kidney Function Receiving Contrast Media (NCT NCT01873859)

NCT ID: NCT01873859

Last Updated: 2014-06-16

Results Overview

Metformin-associated lactic acidosis (MALA) was defined as an arterial pH \<7.35 and plasma lactate concentration \>5 mmol ⁄ L.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 166 participants
• Primary outcome timeframe: 48 hrs
• Results posted on: 2014-06-16

Participant Flow

Participant milestones

Measure	On-metformin Diabetic patients receiving contrast media without discontinuing metformin. Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.	Off-metformin Diabetic patients receiving contrast media with discontinuation of metformin.
Overall Study STARTED	83	83
Overall Study COMPLETED	83	79
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Measure	On-metformin Diabetic patients receiving contrast media without discontinuing metformin. Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.	Off-metformin Diabetic patients receiving contrast media with discontinuation of metformin.
Overall Study Withdrawal by Subject	0	4

Baseline Characteristics

Safety of Continuing Metformin in Diabetic Patients With Normal Kidney Function Receiving Contrast Media

Baseline characteristics by cohort

Measure	On-metformin n=83 Participants Diabetic patients receiving contrast media without discontinuing metformin. Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.	Off-metformin n=79 Participants Diabetic patients receiving contrast media with discontinuation of metformin.	Total n=162 Participants Total of all reporting groups
Age, Continuous	61.57 years n=5 Participants	60.1 years n=7 Participants	60.9 years n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	40 Participants n=7 Participants	83 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hrs

Metformin-associated lactic acidosis (MALA) was defined as an arterial pH <7.35 and plasma lactate concentration >5 mmol ⁄ L.

Outcome measures

Measure	On-metformin n=83 Participants Diabetic patients receiving contrast media without discontinuing metformin. Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.	Off-metformin n=79 Participants Diabetic patients receiving contrast media with discontinuation of metformin.
Incidence of Lactic Acidosis	0 participants	0 participants

PRIMARY outcome

Timeframe: 48 hours from the baseline

Outcome measures

Measure	On-metformin n=83 Participants Diabetic patients receiving contrast media without discontinuing metformin. Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.	Off-metformin n=79 Participants Diabetic patients receiving contrast media with discontinuation of metformin.
Change of Baseline Creatinine 48 hr After Recieving Contrast Media in the Presence or Absence of Metformin Use.	1.05 mg/dl Standard Deviation 0.116	0.99 mg/dl Standard Deviation 0.159

Adverse Events

On-metformin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Off-metformin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Saeed Alipour Parsa, director of clinical trial

Cardiovascular research center, Shahid Beheshti University of Medical Sciences

Phone: +9821 2208 3106

Email: s_alipour@sbmu.ac.ir

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place